Wearable neurostimulation system with curated therapy

ABSTRACT

Systems and methods for providing curated neurostimulation are disclosed such that users are enabled to provide improved therapy in a home environment. Stimulation protocols can be assessed to provide improved targeted stimulation of a nerve and less unwanted side effects. Sets of stimulation montages and associated weights are defined and are selected or adjusted in pre-defined using pre-defined operations that simplify adjustment of characteristics of the stimulation field such as the geometry and location of the provided stimulation. Stimulation matrix pads are arranged and activated to provide advantages. Strategies for adjusting the intensity of the stimulation field incorporate weighting values in non-primary channels and are disclosed. Curated neurostimulation can also include providing defined schedules for events and activities related to the therapy such as providing schedules for stimulation treatment, surveying a user, providing education and remote user support. Features related to decreasing and managing risk of skin events are included as part of the therapy. Both wearable and implanted embodiments are disclosed.

REFERENCE TO RELATED APPLICATIONS

This application is based upon Provisional Application Ser. No.63/052,192 filed on Jul. 15, 2020.

INCORPORATION BY REFERENCE

This application incorporates by reference Provisional Application Ser.No. 63/052,192 filed at the United States Patent & Trademark Office onJul. 15, 2020.

FIELD OF THE INVENTION

The invention relates to the field of stimulating biological tissue toimprove the health or wellness of a user.

BACKGROUND

Stimulation of biological tissue can be used to improve health andwellness. Stimulation of peripheral tissue may cause changes at bothperipheral and central sites in the treatment of disease or for thepromotion of wellness by modulating the function of organs. Stimulationof the vagus nerve(s) is a good example of stimulation at a peripheralsite in the neck that modulates brain and heart activity and producesystemic changes in immune and metabolic activity. Stimulation ofcranial nerves can provide relatively non-invasive treatment options forconditions such as headache or migraine rather than requiring directstimulation of brain tissue. Bioelectronic medicine is progressivelydrawing increased focus as a non-pharmaceutical treatment option forvarious diseases.

Stimulation of peripheral sites to treat unwanted symptoms, medicaldisorders, and conditions, or to promote health or create desiredresults in the brain or body, is attractive since this can providebenefit without the risks and invasiveness of direct stimulation oforgans such as the brain or heart. Target stimulation sites in limbareas such as the arms, hands, legs and feet have been shown to providebenefit in treating, or improving symptoms of, a wide array ofdisorders. Candidate sites can be stimulated, and stimulation parametersand treatment schedules can be assessed for medical benefit in anindividual or population of individuals who have been diagnosed (or“self-diagnosed”) with a medical condition. Unwanted symptoms or statesrelated to, for example, the following: pelvic floor disorders;hypertension; digestive disorders; pain; immunological or metabolicdisorders or states, obesity; attentional, psychiatric or cognitivedisorders; appetite; and other disorders, symptoms, or states which maybe typically treated with medication can be treated with electricalstimulation which provides less risks of side-effects or druginteractions. Stimulation of nerves of the leg, arm, or neck may offersites for a wide treatment of common disorders including cardiovasculardisorders such as hypertension.

Stimulation of nerves in the lower leg offer opportunities to treatdisorders such as pelvic floor disorders that include urinary and fecalincontinence which may manifest with pathology related to urge (e.g.,overactive bladder or “OAB”). The inventors have shown that saphenousnerve (SAFN) stimulation for treatment of OAB symptoms has many benefitscompared to other candidate peripheral neuromodulation targets (e.g.,preferred sensation of stimulation, less affected by edema, strongertreatment response and less risks). When stimulating nerves in the legusing wearable non-invasive neurostimulators advantages are obtainedwhen the target nerves are successfully stimulated while decreasing riskof, or avoiding, stimulation of non-target nerves and/or tissue such ascalf muscle.

Systems and methods which allow easy control of stimulation fieldcharacteristics (e.g., shape, strength, orientation, location, perceivedintensity, and vector summation) should improve nerve modulationtreatment and resulting therapy outcomes. Systems and methods are neededfor allowing easy adjustability and confirmation of the correct settingsof stimulation field characteristics. Operations related to selecting,adjusting, and assessing stimulation field characteristics can becarried out by a patient following instructions and providing feedback,a medical professional in the setting of a medical clinic, at home by auser or caregiver, or a combination (e.g., remote telemedicine).

Novel hardware and software controls and components; algorithms andlogic flows; curated provision and adjustment of the therapy regimenfeatures such as selection or assessment of stimulation fieldcharacteristics, curated treatment support and scheduled treatmentevents provided by a digital ecosystem would provide benefits overexisting therapies. Additionally, an easy onboarding process;instructional exercises and content; patient education about thetreatment on the disease, and on treatments and behaviors that canimprove symptoms; compliance prompts and trackers; and, other novelfeatures of the invention will now be disclosed.

SUMMARY OF INVENTION

An object of the invention is to provide for improved peripheral nerverecruitment of target nerves using curated field steering realized bysystems and methods incorporating novel software and hardware solutions.

An object of the invention is to provide sets of weighting values usedto adjust the amplitude of stimulation provided for sets of stimulationchannels to provide smooth transitions between sets of stimulationchannels.

An object of the invention is to provide software-based artificialintelligence/machine learning program for obtaining user responses andoperating upon these to establish improved stimulation protocolcharacteristics.

An object of the invention is to provide systems and methods that permitadjustment of the location, geometry, depth of electrical fieldpenetration or other stimulation field characteristics without thesubject experiencing unwanted jumps in sensation of stimulationintensity which hinder a user's ability to make comparisons across a setof candidate settings.

An object of the invention is to realize strategies which incorporate:a) neural targeting in which the risk or amount of undesired stimulationof collateral nerves or adjacent muscle is reduced; b) use of weightingfactors to allow adjustment of the stimulation field without producingsharp transitions in the strength or perception of stimulation; c) theprovision of sensory masking stimuli that permits a preferred sensoryexperience and/or decreases discomfort.

An object of the invention is to provide guided adjustment of a set ofstimulation field parameters to provide for improved nerve targeting andavoid stimulating non-desirable tissue, such as calf muscle, shin boneor cutaneous nerves and branches which can cause discomfort and even bedangerous for some users (e.g., ambulatory users, since this may causestrain, tearing, or loss of control of muscles).

An object of the invention is to configure stimulation parameters toprovide stimulation with cutaneous nerve fiber types or receptor types(mechanoreceptors, thermoreceptors) and processing of modalities such astouch, pressure, vibration, and temperature to serve as a sensory mask.

An object of the invention is to configure stimulation parameters todecrease unwanted stimulation of cutaneous nerve fibers and receptors(e.g., nociceptors for nociception pain) through targeted nervestimulation.

Another object of the invention is to provide an adjustable level oftuning for a stimulation field controller which includes at least 2levels of specificity for adjustment such as “Coarse” and “Fine” thatmay be selected by a user.

Another object of the invention is to provide at least one modality ofstimulation that provides an adjunct stimulation signal (which may alsobe termed a “distractor” or “mask” signal) before or during thetreatment stimulation, wherein the mask signal serves to improve thesubjective experience of the stimulation and may decrease the sensationof pain and/or increase stimulation tolerance and which may allow alarger stimulation signal to be supplied without the user experiencingpain or discomfort.

Another object of the invention is to provide at least one modality ofstimulation that provides a stimulation mask simultaneously with thetreatment stimulation signal, wherein the stimulation mask is providedby adjacent electrodes at an intensity level that is lower than thatprovided by primary channels of stimulation.

Another object is to provide systems and methods that permit selectionof an improved stimulation montage for stimulating a target nerve.

An object of the invention is to provide for the incorporation of“guarded” or ‘blocked” stimulation montages and user controls that allowusers to adjust stimulation using gestures on a touch sensitive displayto focus or restrict the stimulation field or avoid stimulation of anarea.

Another object is to provide combinations of anode and cathodeassignments to stimulation pads to shape a stimulation field to increasethe depth of the stimulation from the skin surface.

Another object is to provide combinations of anode and cathodeassignments to stimulation pads to selectively modulate target tissuewhile avoiding tissue areas which cause unwanted side effects (e.g.,other nerves, calf muscle, neck muscle, or a muscle in the arm whenstimulating a nerve target in the arm to modulate cardiaccharacteristics such as blood pressure).

Another object of the invention is to provide a curated “Restore”neurostimulation treatment induction program that guides a user with ascheduled treatment program across a predefined interval.

Another object of the invention is to provide a curated “Maintain”neurostimulation treatment maintenance program that guides a user with ascheduled treatment program.

Another object is to provide remote or software-based coaching (e.g.,behavioral therapy and nutritional education), and presentation ofeducational and survey items that are tailored to educating, surveying,assessing, tracking, and adjusting therapy of an individual based, andfurther adjusting these based upon user behavior and input (e.g.,changes in symptom scores compared to a baseline score).

Another object is to combine stimulation therapy with behavioral therapy(e.g., guides and prompts related to, for example, times foreating/drinking, exercise, etc.), nutritional information, and otherguidance and information to improve the overall therapy benefit.

Another object is to provide treatment of a medical disorder which isconfigured for at-home guided treatment of a user with little, if any,management by a medical professional or, alternatively, with scheduledtelemedicine management provided by medical professionals.

These and other objects of the invention are disclosed in the remainderof this application.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1a shows a neurostimulator system including neurostimulator,stimulation matrix of stimulation pads, wearable wrap, and a user devicewith a user interface screen that controls stimulation parameters.

FIG. 1b shows a neurostimulator with controls, a display and ports.

FIG. 1c shows a wrap having an interface guide with a directionallykeyed aperture, a neurostimulator (view of bottom surface), anddirectionally keyed connectors of a stimulation matrix and aneurostimulator.

FIG. 2 shows modules of a neurostimulation system realized in theneurostimulator, and user devices including remote server computers of atelemedicine service or doctor clinic.

FIG. 3a shows an embodiment of the stimulation matrix.

FIGS. 3b to 3f show exemplary user interface screens for controllingstimulation montages provided with the stimulation matrix.

FIGS. 4a to 4e show embodiments of various stimulation matrix designs.

FIGS. 5a to 5j show embodiments of user interface screens for allowingcurated user adjustment of stimulation field characteristics of thestimulation matrix.

FIGS. 6a to 6n shows embodiments of different activation montagesprovided by the stimulation matrix, with anodes (“A”), cathodes (“C”)which are activate (non-shaded) or inactive (shaded).

FIGS. 7a to 7c show stimulation matrix embodiments including sets of4-sided stimulation pads.

FIGS. 7d to 7e show stimulation matrix grid arrays having 8 rows ofpads.

FIG. 8a shows a method for establishing treatment stimulation with a setof stimulation montages.

FIG. 8b shows a method of providing onboarding, induction andmaintenance according to features defined for a curated treatmentregimen.

FIG. 8c shows a method for managing treatment to deter skin events andpromote good skin health as may occur according to user preferences andrisk scores of a user profile.

FIGS. 9a to 9k show example user interface screens of a digitalecosystem that guide, inform, and obtain user input as part of a curatedtreatment program of a disorder such as a pelvic floor disorder and morespecifically OAB.

FIGS. 10a to 10k show additional examples of user interface screens of acurated treatment program of digital ecosystem that permit user controlof stimulation and screens related to behavioral coaching and education.

FIG. 11 shows long term study results of benefits after 6 and 12 monthsof treatment supporting an induction period of over 21 days for OABtreatment using daily stimulation of the SAFN.

FIG. 12 is a schematic drawing showing a projecting flange extendingfrom a supporting ring or push nut adhered to a stimulation pad.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

While specific embodiments may deviate, the following terms generallymean the following:

Subject, patient, or user are used interchangeably. A user providesstimulation to himself/herself in an at-home setting or is a medicaltechnician controlling the neurostimulator in a clinic setting, acaregiver, a medical professional controlling the neurostimulatorremotely using the internet or a wireless communication channel (e.g.,WIFI or cellular network): the user may not be the person receivingtreatment. Subject may refer to a participant in a research study.

Anode and cathode are designations for the initial phase of a biphasicpulse. While use of biphasic stimulation signals may cause theanode-cathode designation to switch during the provision of stimulationsignals, the designation represents a stimulation circuit that issupplied by at least two channels of a stimulus generator.

Stimulation pad is a conductive substrate that is applied to thepatient's skin and is used to provide an electrical stimulation signal(also termed “conductive pad” or “electrode”)

Stimulation channel is an electrical pathway terminating in astimulation pad and for purposes of this disclosure may also beconsidered to be part of at least one active stimulation pad serving ascathode or anode or an inactive pad. When stimulation is provided byother modalities, then individual transducers for magnetic, sonic,vibration or other type of energy then can each be considered astimulation channel.

Stimulation circuit is at least one cathode and anode; Primarystimulation circuit/channel refers to the channels providing the highestamplitude signals; Stimulation matrix (or “matrix”) is a set of 3 ormore conductive stimulation pads that serve as an “electrode array” forproviding transcutaneous electrical stimulation.

Stimulation signal “strength”, “amplitude”, and “intensity” maygenerally be used interchangeably, provided however, it is understoodthat perceived intensity may also be increased in other manners such asmaking the pulse duration longer which increases total charge delivered.

Horizontal “x-axis” or “Left-Right” axis of the stimulation matrixgenerally spans across the limb, while the proximal-distal axis (i.e.“vertical” or “y-axis”) aligns with the axis of a user's limb. Ifsecured to the left leg, then “left” is closer to the shin and right iscloser to the calf-muscle. The opposite occurs on the right leg. Thehorizontal and vertical adjustments are typically orthogonal. When thereis both horizontal and vertical offset between channels then these are“diagonal”.

Rows and columns of the stimulation matrix refer to stimulation circuitsdefined and distributed with an approximately horizontal or verticalorientation.

Stimulation matrix geometry refers to the arrangement of, and spacesbetween, the activated pads on a stimulation matrix, and may also referto the shapes and sizes of individual pads.

Stimulation protocol defines the stimulation montage and the stimulationsignals sent to each channel of the stimulation matrix which result inthe stimulation field characteristics produced by the stimulationmatrix. This also refers to characteristics of scheduled stimulationsessions (e.g., timing and duration of scheduled treatment sessions).

Stimulation montage includes the designation of each stimulation pad ofa matrix (e.g., anode, cathode, inactive), and the weights used at eachchannel (typically to scale amplitude, but also able to affect otherwaveform parameters such as pulse width). The stimulation montage ispart of the stimulation parameters that define the signals supplied fromthe matrix (active geometry+stimulation signals). The stimulationmontage provides a profile of activated pads of the stimulation matrix.

Stimulation field geometry is the shape of the vector electrical fieldinduced in the user's body.

“Recruiting” and “modulating” a nerve indicates influence of theelectrical field on neural activity, and typically indicates influencingthe activity of the nerve by initiating action potentials.

Skin stimulation threshold is stimulation that is sufficient to causestimulation to be perceived at the cutaneous area under one or morestimulation pads.

Target nerve threshold is stimulation that is sufficient to causerecruitment of a target nerve as evidenced by the perception ofparesthesia moving away from the stimulation pads or at an area distinctfrom the stimulation pads, or evidenced by stimulation evoked sensory ormotor responses.

A therapy regimen includes the stimulation protocol and all treatmentoperations and events that are defined to be provided as part oftherapy.

The Non-invasive Neuromodulation Assistant (NiNA) system refers to thecombination of hardware and software, and the features realized by thedigital ecosystem, that work together to provide the neurostimulationtreatment and advantages of the disclosed invention.

Wearable Neurostimulation System

FIG. 1a shows an embodiment of a neurostimulation system 10 including aneurostimulation device 12 that connects electrically and physically toa stimulation matrix 14 with stimulation pads 16 that are removablyattached to, and deliver electrical stimulation signals through, auser's skin. The device 12 and matrix 14 can be secured to a location ona user's limb (e.g., lower leg) using a garment such as a wrap 18. Thewrap 18 is designed with a long arm 18 a, a short arm 18 c, and a baseregion 18 b therebetween which is configured to engage with the device12. A user device 20 is realized as a smartphone running Android or iOSand operating a mobile app 21 which allows a user to communicate withand control the neurostimulator 12. The control of selected treatmentparameters may be constrained according to permissions allowed by acurated therapy regimen which may be adjustable or be predefinedrestrictions. Stimulus generation electronics of a stimulation module ofthe device 12 provides stimulation under control of the device's controlmodule to provide stimulation signals to the stimulation matrix 14during treatment. In an embodiment, the stimulation circuitry of thedevice 12 provides independent, current controlled stimulation channels,so that each stimulation pad 16 of the stimulation matrix 14 serves ascathode, anode, passive ground return. Each Pad has its own power sourceallowing for precise control at each pad so that what is specified isthe actual stimulation field that is provided and maintained.

In an embodiment of the neurostimulation system 10, there is provided astimulation module 42 having an electrical stimulus generator thereinwhich transmits electrical signals through a plurality of electricalgenerator channels. A control module 40 is electrically coupled to theelectrical stimulus generator for activating or deactivating each of theelectrical channels in accordance with a predetermined protocol having aset of at least two stimulation montages with a weighting value definedfor each of a set of activated pads (seen in FIGS. 6a-6n ). Astimulation matrix 14 is provided defining a plurality of pairs ofelectrical stimulation pads 16 which are positioned in a fixed andpredefined arrangement on a user's skin. Each of the pairs of electricalstimulation pads 16 has an anodic and a cathodic pad electricallycoupled to a respective cathodic and anodic electrical generatorchannel. Each of the electrical stimulation pads 16 are either in anactive state when a respective electrical generator channel is activatedor in an inactive state when a respective electrical generator channelis deactivated.

A first stimulation montage (any one of the stimulation matrices 14shown in FIGS. 6a-6n ) is defined for the stimulation pads 16 of thestimulation matrix 14 where each of the electrical stimulation pads 16is in an active or inactive state. At least one second stimulationmontage is defined for the electrical stimulation pads 16 of thestimulation matrix 14 where at least one of the electrical stimulationpads 16 is in an inactive state when at least one stimulation pad 16 isin an active state in the first stimulation montage. A user interfacedevice 20 permits the user to cause transitioning the stimulation matrixfrom the first stimulation montage to the second stimulation montage.

While an object of the invention is selective targeting of the saphenousnerve (SAFN) for treatment of overactive bladder (OAB), in alternativeembodiments any nerve (or combination of nerves) in the leg, especiallythe lower leg at or below the level of the knee, (e.g., the saphenousnerve, sural nerve, posterior tibial nerve, tibial nerve, peronealnerve) may be stimulated to treat a wide array of symptoms anddisorders. The invention may also be used to stimulate other limbs orbody parts, such as at least one arm of a user.

FIG. 1b shows an embodiment of a neurostimulator device 12 having ahousing formed as a durable plastic enclosure containing electronics andpower. The top housing portion 24 a has a power button 22 andstimulation field controls that allow user adjustment of the stimulationamplitude 26 a,26 b and location 26 c,26 d, a display such as a touchsensitive display 30 that provides information relating to stimulationfield amplitude 30 a (or “intensity”) and location 30 b, and otherinformation 30 c (e.g., treatment session elapsed time/time remaining;battery power level; number of remaining stimulation sessions or daysbefore the matrix 14 must be replaced). The housing 24 also has at leastone port 32 allowing for exchange of data/power signals. This can beconfigured to receive a connector having a set of electricalchannels/contacts (e.g., USB, lightning cable connector, or pogo pinswith magnetic retention), and have a corresponding set of electricalchannels/contacts which route signals to modules of the device 12 (e.g.,power, communication, or control modules), and can allow for wiredcontrol of, or data/power communication with, the device 12.

The device controls allow the user to start, stop, and pause stimulationby causing corresponding operations to occur in a control module. Forexample, after a therapy session has started pressing the power button22 for ^(˜)1 second pauses or restarts the stimulation, while holdingthe button 22 for longer (e.g., 2 seconds) causes shut-down operationsto occur (e.g., updates device memory and then turns it off or sets itinto a lower power standby mode as per step 132 of FIG. 8b ), orpressing buttons 26 a,26 b to increase or decrease the amplitude ofstimulation pulses, or perform “field control” 26 c,26 d that can changecharacteristics of the stimulation field such as location. Field controlimproves capture of a target nerve (e.g., the SAFN) while minimizingstimulation of surrounding nerve and muscle tissue (i.e., nervetargeting increases selective activation). Field controls providesadvantages such as obviating a trial-and-error method of stoppingstimulation, relocating stimulation pads, and re-starting thestimulation. The touch sensitive display 30 indicates stimulation fieldcharacteristics using either graphical or text-based information, andmay also provide a simple user interface. The characteristics includeinformation about, for example, stimulation intensity 30 a,location/geometry of the stimulation montage 30 b, and other information30 c (e.g., stimulation status Off/On/Paused, Time left). Theneurostimulator device 12 can also operate additional input/outputaccessories (1/O components, sensors, or transducers) such as a camera38 a that allows the neurostimulator device 12 to scan and trackrelevant information about other system components (e.g., barcodeinformation of a disposable stimulation matrix) or take pictures of apotential skin problem. Another 1/O component is a speaker 38 b that canprovide auditory cues related to treatment operations (e.g., provide atone if the stimulation matrix is not attached correctly).

FIG. 1c shows an embodiment with a garment such as a leg wrap 18realized as a flexible/fabric wrap that secures the neurostimulator 12and stimulation matrix to a user's upper calf area during treatment. Thebottom housing 24 b of a neurostimulator 12 is configured with a shaped(or “keyed”) device connector 34 a to engage with (physically andelectrically) a shaped matrix connector 34 b provided on the top side ofa stimulation matrix to secure both connectors to each other and throughthe wrap 18 with an intended or orientation. The neurostimulator 12includes a stimulation module having signal generation circuitry fordelivering electrical stimulation pulses to the pads of the stimulationmatrix through electrical channels/contacts 35 a,35 b (not shown) of theconnectors 34 a,34 b to provide a plurality of independently controlledstimulation channels. Each channel of the set of channels/contacts 35 aof the shaped connector 34 a of the neurostimulator 12 connect to, ormay be dynamically routed to, 1 or more channels of signal generationcircuitry of at least one pulse generator of the neurostimulator.Accordingly, the stimulation pads of the matrix may be independentlycontrolled to provide selected stimulation signals and to be active(e.g., anode, cathode) or inactive.

In embodiments, the connectors 34 a,34 b are shaped asymmetrically toonly permit engagement with a pre-determined physical orientation. Thekeyed connection between device 12 and matrix 14 is established througha keyed aperture in the interface guide 33, and can use magnets 36 toform a magnetic connection between the matrix and neurostimulatordevice. Magnets 36 provided for the two halves 34 a,34 b of theconnector assembly allow these to “snap” together when properly alignedprovide a secure connection between the corresponding electricallyconductive channels 35 a,35 b. The keyed connectors have an arrow shapeso that the UP direction is intuitive to the user (e.g., arrow points UPwhen worn on the leg). As such, the “female/lock” portion of theconnector 34 a forms an “arrow” outline which matches corresponding“male/key” shaped connector 34 b of the matrix, and corresponding shapedopening in the wrap. The connector 34 a on the bottom of theneurostimulator 12 housing, connector 34 b on the top of the array, andthe aperture of the interface guide 33 of the wrap 18 are all keyed tocause proper application of these three system components duringtherapy.

In embodiments, the shaped connector 34 a and electricalchannels/contacts 35 a are configured to also connect with a customadaptor (not shown) to provide for communication of power/data signalswith a user device 20 connected to a cable. Some of the electricalchannels/contacts 35 a are configured to route signals to a power orcommunication module of the neurostimulator device. In other words, theconnector 34 a that is connectable to a stimulation matrix, may alsohave contacts that allow it to serve as a system interface for chargingor communication purposes.

In embodiments, the shaped connector 34 b of the matrix has electronicsfor providing functionality such as a readable unique ID 37 (see FIG. 3a). A unique ID 37 may be realized using a microchip or RFID chipintegrated into the connector 34 b that uniquely identifies eachstimulation matrix (e.g., with a serial number) to a neurostimulatordevice using wired (e.g., through connector 34 a) or wireless (e.g.,RFID) means. Alternatively, a matrix may have a unique ID 37 displayedas a bar or QR code 37A (see FIG. 3a ) that is read by an I/O component38 such as a camera 38 a of the neurostimulator (see FIG. 1b ) or ofuser device 20. The ID information can be operated upon by theneurostimulator or can be transmitted from the neurostimulator to a userdevice where it is processed by a system module (e.g.,evaluation-management module 46 of FIG. 2). As will be discussed in FIG.2, the ID information 37 can be processed by software of a userinterface module 48 and operated upon by an evaluation-management module46 to determine if the matrix meets compliance criteria of a matrixmanagement module 49, such as whether the matrix has been used less thana maximum permitted number of treatment sessions or cumulativestimulation times.

Connective Wrap

In embodiments, the system uses a flexible, stretchable fabric wrap 18with a base region 18 b and two tapered wing regions 18 a,18 c or“arms”. The base region 18 b contains an interface guide 33 having arigid frame containing a shaped aperture allowing shaped connectorportions 34 a,34 b to engage. The wrap, interface guide, and shapedconnectors collaborate to promote correct use by: a) correctlypositioning and orienting the neurostimulator and matrix (whenstimulating the SAFN the matrix should located on the medial aspect ofthe leg and a tab portion 52, if provided on the matrix, should belocated at the top with the neurostimulator display having the intendedorientation to display information to a patient); b) securing the matrixand device to the patient's leg during therapy; c) providing adjustable,suitable and comfortable pressure against the skin, and d) providingunobstructed access to device display and user controls.

As shown in FIG. 1a , in one embodiment the wrap is sandwiched betweenthe matrix 14 and the device 12. This is then wrapped around thepatient's upper calf area so the matrix is located over a portion of theuser's SAFN. Velcro or similar attachment material can be used to securethe arms 18 a,18 c to each other. Additionally, adjustable straps may beprovided on the arms of the wrap to allow the user to adjust thetightness of the wrap 18. The shape of the wrap can be important sincethe SAFN is a sensory rather than motor nerve that is selectively orprimarily stimulated during therapy. Accordingly, patients should beable to engage in ambulatory activity without worrying about unwantedmotor movement or muscle injury. In embodiments, the wrap is orientedand biased to be asymmetric on its top and bottom edges to provideimproved fit. For example, the bottom is shaped with steeper angles onits bottom edges that engages the calf muscle area, than on its proximalend to better match the shape of the leg and calf muscle. The improvedfit around a user's calf region can provides support, and decreases therisk of improper fit or migration if patients are ambulatory duringtherapy. The wrap 18 can be formed of known biocompatible materials(e.g., mixtures of Polyester, and other breathable fabrics such asLycra, spandex, elastane, stretchy yarn). In embodiments, the wrap isformed of 1-4 layers of material to produce a net result of stable ormoderate stretch (e.g., 0-100% stretch) as may be realized using weavesor other designs that allow for 2-way or 4-way stretch.

In an alternative embodiment the wrap 18 may be realized as a flexiblesubstrate having conductive stimulations pads (e.g., dry or reusableelectrodes) on its bottom surface which are adapted to be connected tothe neurostimulator and apply stimulation to the skin of the user.Rather than a wrap the system may be used with a garment such as a sockform factor with electroconductive regions.

Neurostimulation System Components & Modules

FIG. 2 shows embodiments of components and modules of a neurostimulationsystem 10 a. Modules may be realized within the housing of aneurostimulator 12 and also within other system components such as thematrix 14, the wrap 18, and user devices 20. The modules contain thesoftware (computer code), algorithms and rules, hardware/electroniccircuitry, user interface components (e.g., transducers andtransceivers), and other resources required to provide the featuresascribed to the module which enable the system 10 a to function. Modulescan be realized, and resources shared, in a distributed manner acrosstwo or more components of the system 10 a. For example, the userinterface module 48 of the neurostimulator device 12 or of the userdevice 20 can accept user input, operate upon this input, andcommunicate the output of the operation to the other device so that bothdevices of the system 10 a operate collaboratively to provide theintended therapy. Rather than having electronics (e.g., stimulusgenerating, control, and/or routing circuitry) realized within theneurostimulator housing, an electronic assembly can be attached to thetop of the stimulation matrix, connected with the housing of theneurostimulator, and controlled by a processor of the control module 40of the neurostimulator 12. Accordingly, modules disclosed as existingwithin the neurostimulator housing, can typically be realized in leastone user device 20, or other system component.

The control module 40 of the neurostimulator 12 has a processor forimplementing computer code instructions related to the provision oftherapy and device operation. The control module also has timers, a realtime clock, memory, and is understood to incorporate any circuitrytypically available in, and well known to exist in, consumer electronicssuch as smartphones, health tracking wearable devices, and devicescommonly used for providing electrical stimulation to a user at home orin a clinic. The control module 40 also contains all the treatmentparameters and protocols, schedules, algorithms, and rules that are usedto provide one or more curated treatment programs. In embodiments, thecontrol module 40 is configured to implement a plurality of featureswith a treatment regimen that enable a user-friendly experience whenusing the system 10 a. Features related to a curated onboardingexperience, user training, and scheduled treatment, user friendlyadjustment of stimulation protocol parameters which provides improvednerve modulation and perception of stimulation, coaching, education andsupport activities (and other features that will be disclosed) arerealized by the digital ecosystem.

The power module 41 has a rechargeable power supply that allows formultiple uses between recharges. It may also have a primary cell or acombination of the two. Recharging may occur using wired rechargingprovided through a port 32, through connector 35 a via an adaptor, or bywireless inductive charging circuitry of the power module 41. The powermodule also has power management, safety, isolation and monitoringcircuitry to provide power related operations.

The stimulation module 42 includes one or more stimulus generators withcircuitry to generate one or more channels of stimulation for providinga stimulation signal according to a stimulation protocol. Thestimulation module 42 includes circuitry for allowing impedancemeasurement and adjusting signals in relation to the measurements. Themodule includes processing circuitry (e.g., analog and digital signalconditioning modules, filters, amplifiers, DA/AD circuitry, memory,clocks and timers, switches, and multiplexors) for production andcontrol of stimulation signals. In embodiments, one or more signalgenerators are configured to control the stimulation provided to each ofthe stimulation matrix pads, so each of a plurality of stimulating pads16 is independently assignable to be active (e.g., anode or cathode) orinactive. The stimulation module is configured to provide stimulationsignals according to stimulation parameter protocols to the activestimulation pads.

In embodiments, when the stimulation matrix has 6 stimulation pads, themodule allows each of the 6 pads to operate as a programmable,selectable electrode, according to parameters defined in the stimulationprotocol. Multiple stimulus generators allow independent control of aplurality of stimulation signals which may be provided on a simultaneousor interleaved basis. The characteristics of multiple channels ofstimulation can be controlled to provide field steering functionality.Constant current and constant voltage stimulation circuitry may be usedby the stimulus generator. The stimulation circuitry of the stimulationmodule 42, and the sensing circuitry of the sensing module 44 may beconnected to any of stimulation matrix pads through channels 35 a of ashaped connector 34 a on the bottom surface of the device housing 24 b.

The stimulation module 42 provides user-friendly and simple adjustmentof stimulation protocol parameters that affect the location and shape ofthe stimulation field using NiNA's “SaphLocate” features as will bedescribed, which includes some of the following:

a. The stimulation module 42 also contains sets of defined stimulationmontages which include channel assignments (anode, cathode, inactive),and channel weighting values (which may be based upon the amplitude ofthe electrical signals transmitted by the electrical stimulus generatorand other parameters such as pulse duration, frequency, etc.) that areused to adjust the stimulation signals that are provided by eachstimulation channel (i.e., at each stimulation pad). It may includetables of channel weighting values (also termed “weighting factors” or“weighting values”) that are used to adjust the stimulation signals thatare provided to a user through each stimulation channel.b. The stimulation module 42 also contains distinct sets of definedstimulation montages which are selected when a) a user is assessingdifferent stimulation montages during training or assessment that mayoccur prior to providing treatment stimulation; and, b) a user isproviding stimulation therapy during treatment. The module also containssets of stimulation montages that are defined for either “coarse” or“fine” resolution adjustment.c. The stimulation module 42 also contains sets of stimulation montagesthat have been defined to be used in a series when a user adjusts thestimulation field in a defined direction (e.g., a left-right orproximal-distal). The module also contains algorithms or rules foraccessing look-up tables that define how a stimulation montage isadjusted or selected according to user input using field steeringcontrols, or circuits that allow similar adjustment. The module isconfigured to permit adjustment of stimulation montages to occuraccording to a predefined sequence of stimulation templates. Theselection or adjusting of at least one stimulation field characteristicwhich is defined by the stimulation templates can include, for example:a) the location of the stimulation field, the spread of the field, andthe fall-off of the field, as will be disclosed.

In embodiments, the stimulation module 42 signal generators areconfigured to provide stimulation signals including pulse trains,bursting, sinusoidal waveform (0.1 Hz to >50 kHz), arbitrary waveforms,band limited noise (narrow or wide band), inferential electricalstimulation which is provided using multiple channels of a stimulationmontage to provide targeting capability.

The memory module 43 manages storage and retrieval of data created orused by other modules of the system. For example, it can manage orsearch log data (generated by the log module 50 m), store libraries ofvideo content (used by the reference materials module 50 a) used toprovide educational and behavioral coaching, instructional content, andreference information that is accessed or operated upon by variousmodules of the ecosystem module 50. The module provides databasefunctionality and manages lookup tables of other modules to store andretrieve values related to stimulation parameters, treatment protocols,and user defined parameter values and input such as responses to surveyitems or user preferences. The memory module may also manage contentthat is stored and updated in a web storage resource (i.e., in the“cloud”) or on remote computers 20 f.

The sensing module 44 includes circuitry for operating the sensors suchas accelerometers, electrodes that can sense impedance or physiologicalmeasures which can be sent to the evaluation-management module toevaluate measures such as heart rate, evoked nerve potentials (e.g.,evoked compound action potentials “ECAP”, sensory nerve actionpotentials “SNAP”), or evoked EMG responses. It may also contain opticalsensors (e.g., for measurement of heart rate or blood oxygen levels),and sensors for obtaining data related to moisture, skin temperature, orderiving cardiac measures such as blood pressure, etc.

The communication module 45 provides all circuitry and softwarealgorithms required for the system components to communicate betweeneach other or with other devices. For example, the system componentsshown in FIG. 2 include a series of user devices 20 which cancommunicate with the neurostimulator 12 to allow user control of thestimulation therapy. The module contains circuitry and operatinginstructions to allow system components to “handshake” and communicatesecurely and wirelessly using Bluetooth, WIFI, and other wirelessprotocols. In an embodiment, the communication module updates a contactlog in the log module 50 m based upon inter-device communication.

An evaluation-management (EM) module 46 contains protocols forevaluating sensed data, such as a) deriving evoked potential data (e.g.,operating signal processing algorithms to derive measures of averagedSNAP data), b) assessing accelerometry data or EMG data to determine auser state or activity level (e.g., walking, running, sleeping, or lyingdown). The EM module 46 is also configured to operate the memory module43 to store a log/history of device operations including durations,intensities, and other parameters used during stimulation, sensedpatient activity levels or positions, etc. The module also evaluatesimpedance sensed by the sensing module 44 and can manage deviceoperation if impedance measurements fail impedance criteria by operatingaccording to “improper impedance” rules. Defined operations can include,for example, setting a flag in the control module 40 to cause it topause stimulation and/or provide a user alert (by controlling thestimulation module 42 and/or user interface module 48).

The progress module 47 tracks the progress of a user and goalachievement. For example, the module contains algorithms that calculatea first symptom score of the user at baseline (e.g., calculated usingdata obtained across 3 days before or after the start of therapy) usingresponses to surveys presented by the digital ecosystem module 50. Theuser is again surveyed at one or more later dates (e.g., day 14) and theresults are used to calculate at least one post-treatment symptom scoreand at least one difference score comparing a baseline and apost-treatment score. If one or more symptom scores show improvementsbetween the first and subsequent scores that are above a selectedthreshold, then defined operations occur such as the module may displaya message about treatment progress “Congratulations: you have decreasedyour urinary urge incontinence score by x %”. The module calculates andstores scores at different timepoints, calculates changes in scorescompared to baseline, and displays these to a user as a history ortrendline of the scores at preset times, upon user request, or accordingto a user achieving symptom improvement for a score that exceeds aminimum threshold.

The progress module 47 serves as a progress tracker that tracks anddisplays information to a user related to symptom changes or progressrelated to completing the treatment. A graphical representation of thesteps required to be diagnosed and/or treated can show a user a statuswithin the defined course of treatment. For example, a timeline caninclude initial consultation, completion of a baseline bladder diary orsurvey, a telemedicine diagnosis and prescription, onboarding, aninduction interval, 1 or more timepoints for potential transition tomaintenance, scheduled telemedicine or in-clinic visits, and any otherdefined therapy event.

The user interface module 48 provides subroutines and algorithms foroperating, and responding to, the user interfaces (e.g., controls anddisplays) provided in the housing of the neurostimulator 12 or userdevice 20. The module manages user navigation through various menus andtreatment screens of the user device 20, selection of features providedby the digital ecosystem module 50, and the entering of user input data.The module controls information presented to the user on the display atparticular times (e.g., it can alternate between stimulation intensityand a timer value showing time remaining or elapsed time for therapysession. The module also assists in processing, adjusting, updating, andsynchronizing operating parameter values in response to user inputcommands of a user interacting with the neurostimulator 12 or userdevice 20. The user controls 26 and display 30 of the neurostimulator 12(shown in FIG. 1b ) and touch sensitive display of the user device 20are part of the user interface module 48 and allow user adjustment ofthe stimulation protocol parameters (e.g., amplitude of stimulation viaintensity controls 26 a,26 b, field steering controls 26 c,26 d whichprovide spatial adjustment of the stimulation field at least along oneaxis of the stimulation matrix. Some information presented by the moduleincludes a) session time remaining b) stimulation strength, c)stimulation field location for at least one axis, and d) remainingpower. A touch sensitive display also allows for providing user input tocontrol treatment characteristics.

In embodiments, a user interface module 48 provides a user with voiceprompts for a set of survey items such as “Did you leak today?” whichrequire simple user responses to be selected on the display of a userdevice 20, typed in, or spoken and recorded, transcribed, interpretedand perhaps confirmed (i.e., repeated back to a user), and added to alog. User input/feedback provided by a user is used to modify thetherapy regimen. User verbal responses may be confined to 1 or 2-wordanswers such as a number (e.g., 1-10), or simple answers “Yes”, “No”,“Large”, “Medium”, “Small”.

The matrix management module 49 provides the system with featuresrelated to identifying and using a stimulation matrix. It contains thedate that the matrix was replaced and the amount of time or number ofuses for which a matrix was used. It contains protocols for obtainingand validating the matrix ID information using a validation algorithmwhich may also utilize lookup tables, or by communication with a remotecomputer 20 f.

The digital ecosystem module 50 allows the system to provide additionaloperations related to surveying of a user, adjusting treatment,promotion and assessment of compliance, remote telemedicine features andpatient education, and behavioral training that supplements or enhancesthe benefits of stimulation therapy and additional features of thefollowing ecosystem modules.

The virtual module 50 a includes resources to support virtual oraugmented reality features of the system such as those that can assist auser to align the wearable device in a similar position for separatetreatment sessions. For example, if a user points the video camera ofthe user device at their leg, the software can superimpose a virtualdevice on the user's leg according to a prior placement that was knownto be correct. The module can also contain modelling software thatassists with visualizing a modelled stimulation field which can bepresented to a user. For example, modelling software performscalculations on the stimulation signals that are provided by thechannels of the stimulation matrix and generating a modelled vectorstimulation field which can be graphically shown to a user (e.g., by“heat map” display of current density or other field parameter). Inaddition to simply illustrating the strength of the stimulation signalsat each stimulation pad, the modelling software may also use informationabout the impedance, active/inactive channels, pad shape, and matrixgeometry when calculating the vector field that is displayed to a user.The virtual module 50 a also includes software that allows a user toselect (e.g., tap on an area of a user device display) one or moreregions of an anatomical representation of a user's body to indicate,for example, the lowest area where paresthesia is felt (see FIG. 9h ).

The reference module 50 b includes reference materials, videos and othercontent presented to, or accessed by, the user during an intervaldefined by the treatment regimen. The module also stores informationsuch as photographs taken by the user. For example, if the system isfirst set-up for a user by a doctor then part of the onboarding processdefined in the onboarding module 50 e to operate a digital camera of auser device to obtain a picture the user wearing the neurostimulator 12.The user can view, or prompted by the user device 12 to view, thisreference picture before a therapy session is provided at home toreinforce correct positioning on the leg.

The user groups module 50 c includes resources that support a userinteracting with a user group of individuals who also use theneurostimulation system including, for example, message board and chataccess. Progress of other users who started at the same time as aparticular user can be provided as a means of gamifying the therapyexperience.

The telemedicine module 50 d includes telemedicine capability includingscheduling and connecting to remote medical support for providingvideoconferencing or other remote support (e.g., chat). The telemedicinesoftware may link to the user's smartphone calendar to allow them to setdates for events on the treatment regimen including telemedicine dates.In an embodiment, the system contains computer readable software code inthe user interface module which operates with the other modules tomanage telehealth operations and create a corresponding data log of auser's remote telehealth history. In addition to being scheduled, remotemedicine visits can occur in response to a user response input whensurveyed about whether they have any questions related to therapy. If ascheduled therapy session is set to occur then a “push notification” canbe provided by the App 21, where user is asked if they want to have aremote session or be scheduled for an appointment (via scheduler orphone call). A positive response invokes a scheduling screen where auser can select a date and time for a remote session to occur, includingimmediately.

The onboarding module 50 e operates to guide, train, survey and assistthe user during their first use of the system to set up user preferencesand establish a user profile. In embodiments the module provides acurated progression through a series of interactive screens that includeproviding instructions and exercises about proper system use, surveyingthe user about treatment goals, user information (e.g., age, copingstrategies), user symptoms, user preferences, medical history, etc. Theonboarding information is then used to create a user profile and toadjust therapy protocol parameters.

The survey module 50 f, manages the scheduling and selection of surveyitems presented to a user during onboarding, induction, and maintenancetreatment intervals. The surveying may occur using rules that are, forexample, a) event driven (e.g., if a user indicated improvement of asubjective quality of life (QOL) measure then the system may providefurther survey questions to obtain more information), b) logical (e.g.,if the user indicates nocturia is not a problem the user will not besurveyed further on that topic at future times), or c) scheduled (e.g.,a two week timepoint is reached and a post-treatment assessment shouldoccur).

The user profile module 50 g provides for storing and management of userprofile information.

The coaching module 50 h provides patient coaching and allows for theselection of, and adjustment in the schedule of coaching. Coachingincludes modifying user behavior, cognition, or other attribute whichcan assist with providing improved outcome. Coaching includes providingeducational content, reminders and “nudges” related to informationrelevant to a patient's treatment (e.g., neurostimulation andcognitive/behavioral therapy). The coaching module can be designed toprompt the user to take pictures prior to each at-home therapy sessionto create a visual log that can be reviewed by a medical professional toensure the user has been placing the device correctly.

The alerting module 50 j stores protocols and parameter values used byuser notification operations for promoting compliance of stimulationtreatment sessions or other treatment events.

The locator/connect module 50 k provides features related to locatingphysicians who are familiar with the SAFN therapy and contains (oraccesses remote) information such as physician profiles, distance frompatient's location, patient ratings and comments, contact informationand functionality for scheduling appointments or remote sessions. Canalso filter information based upon a patient's insurance information andpreferences (male/female doctor, alternative medicine specialization,primary care vs urologist, etc.).

The log module 50 m is configured to create a log of all dates, times,and parameters related to the provision of therapy, device operation, oruser input. The log may include timestamped data that allows the userto, for example, interact with the AE module 50 n to create and store aphotographic log to identify and track a potential skin condition (“skinevents”) related to use of the device. Algorithmic support for assessingthe condition over time can assess features of the image related to theseverity of the skin condition. Fields of a contact log can include thetime and content of any user messages that users may send to/receivefrom a remote computer 20 f of a remote medical service (e.g., Q&Abetween a doctor and the user). Additionally, the contact log can storeany information related to user provided “event tagging” which mayinclude voice recordings or text messages which are transmitted to aremote computer 20 f for review or which are stored on the device forlater upload and review by a medical technician. The communicationmodule

The adverse event (AE) module 50 n is configured to provide usersfeatures related to identifying, reporting, logging, tracking andavoiding potential adverse events that may be related to the treatmentsuch as skin reaction events (e.g., redness, soreness, bruising, etc.).For example, if during the onboarding process a user indicates theirskin is prone to irritation then the module can set a reminder to occurprior to therapy session and instruct the patient to alternate the legon which the device is worn, limit the therapy to a selected duration,apply a moisturizing cream after the session, etc.

Rules and algorithms module 50 p is accessed by the control module 40and stores and implements rules and algorithms of the system 10 a. Rulesdefine what occurs according to an operating parameter is set to aparticular value. For example, if a skin risk score variable is set atdefined value then skin risk operations are provided by the treatmentprogram. Rules can implement operations contingently based upon variousthresholds being met or exceeded. The algorithms are used to calculateresults that guide system operation. The rules can also accessoperations defined in look-up tables for defined events so that usersare provided with appropriate therapy events. When users provide rankedscores, then rules can be used to operate on the scores to select one ormore montages for therapy.

FIG. 2 shows a neurostimulator 12 and other components of the system 10a with which it communicates. For example, the neurostimulator 12 canreceive input from user devices 20 such as a smartphone 20 a (or tabletrunning Android or iOS, and an “App” 21 that supports all features ofdigital ecosystem), smartwatch 20 b, laptop or tablet computer 20 c (ofthe user or a doctor), a remote laptop or computer of a telemedicineservice 20 c′, a specialized “remote control” 20 d device (e.g., onlyhaving controls for therapy regimen parameter values to be controlledand communicated to the stimulation device 12, or also having a displayof therapy parameters), an virtual assistant AI technology (e.g.,Alexa—type) device 20 e, a remote computer 20 f that provides datastorage and other functionality. The remote computer 20 f is understoodto be a server computer that may operate as part of at least one “serverfarm” or “data center” that is connected to the internet and enablesremote support of the neurostimulator 12. The remote computer 20 fresources are programmed to provide the features that are disclosedherein including providing remote resources as is well known in the art.

The device 12, user device 20, or other system component is configuredfor 2-way communication with remote computer resources 20 f of a centerthat provides automated or human-based review of patient data,telemedicine support for users, and other disclosed ecosystem features.

The neurostimulator 12 can be used alone or in combination with userdevices 20 a-20 f. In an embodiment, the control module 40 of theneurostimulator 12 can be set in a “device-only” or “stand-alone”default mode which is not toggled to a “user-device” mode until a userdevice 20 establishes communication with the neurostimulator 12. Thiscan occur at the first time use, and a user must confirm on a userdevice 20 a-20 f that they wish to routinely operate the neurostimulatorin combination with one or more of the user devices 20 during therapy,or can occur thereafter. In an embodiment, the user device 20 is asmartphone 20 a operating under control of a software application or“App” 21 that is uploaded to run in the operating system of the userdevice and enable a wide array of functionality. The App 21 provides auser interface to control the neurostimulator 12, provides user alertsrelated to scheduled therapy sessions, presents survey items that a useror medical professional completes to customize a therapy regimen, andprovides a plurality of additional features of a digital ecosystem aswill be disclosed. Alternatively, the user device 20 may be configuredwith limited functionality such as only displaying a few virtualcontrols to toggle between a power ON, power OFF, stimulationpause/restart; and to adjust stimulation parameters such as intensityand predefined sets of active channels of a stimulation matrix. In anembodiment, if the user device 20 is realized in a simple embodimentwith few controls and features then additional functionality andfeatures (e.g., presenting surveys and permitting user input) isprovided through a web portal, or by a user filling out and mailing ore-mailing surveys to a processing entity which enters/scans theinformation into a remote computer resource 20 f of the web portal. Theweb-based portal hosts a remote computer 20 f to allow user creation ofan account for completing survey items and interacting with a webinterface for personalization and customization of their therapyprogram. The information entered in the portal can be operated upon andthen communicated to the neurostimulator 12 or one or more of the userdevices 20 to customize the therapy regimen.

In embodiments, the user device 20 is realized as user's smartphone 20 arunning an App 21 that is configured to alert the user with the speaker(auditory alert), vibration (vibrotactile alert), or display (visualalert) of the smartphone under control of the user interface module 48functionality provided by the App 21. The visual notifications may bepush notifications presented by the App 21, or can be provided as textmessages or e-mails which are provided via the App 21 or which arescheduled to be sent from a remote computer 20 f. The App 21 can also bedesigned to display a dashboard that allows a doctor at a remote serviceto use a remote computer 20 c′ to communicate and monitor/control aneurostimulator 12 of a particular user. When the portable computer 20c′ is used as a dashboard, its control module 40 communicates with thecontrol module 40 of the neurostimulator 12, and the dashboard isdisplayed and interacted with under control of the user interface module48. When a portable computer 20 c′ is used by a physician to monitor andadjust stimulation parameters of a set of one or more remote patientneurostimulators 12 it can communicate directly with theneurostimulators or can operate in conjunction with a server computer 20f which contains information about at least one set of neurostimulators12. The user device 20 may also be realized as a custom remote-controldevice 20 d with or without a display with customized function buttonsfor controlling the stimulation intensity and adjusting location ofactive channels as well as circuitry for providing alerting and userinteraction. The user device may be realized as a voice-based virtualassistant AI technology such as an Alexa device 20 e with softwaremodules that can control an entire smart device ecosystem. TheNon-invasive Neuromodulation Assistant (NiNA™) module is an Alexa“skill” (i.e. function defined in a library) that can be installed andactivated by a user and is programmed to provide functions such as, a)provide reminder alerts, b) allow the user to initiate a treatmentsession, c) provide commands during a treatment session such as thosethat control the stimulation waveform (e.g., “Alexa—increase intensity”,“Alexa—pause stimulation”) d) provide commands which change the locationof the stimulation field according to at least one defined series ofpre-set stimulation montages (e.g., “Alexa—move stimulation to theleft”). A remotely connected server computer 20 f that provides acomputer resource that in turn can communicate with remote laptops 20 coperated by doctors, clinics, medical services, or a manufacturer andwhich provides, for example: a) data storage for at least one set of oneor more neurostimulator devices, managed by a memory module 43 or b) aweb-portal accessed by users over the internet via the user interactionmodule, c) virtual user control and communication with neurostimulators12 permitting viewing of summary statistics for 1 or more sets ofneurostimulators to be displayed on dashboards. In embodiments, theneurostimulators are configured to communicate with a remote computer 20f either directly or by way of the user device 20 a according tostart-up and shut-down routines of the control module 40 which occur atthe beginning and end of each treatment session, or as operationsdefined when switching between a low-power standby OFF state and an ONstate (e.g., to upload log data or obtain permission to provide atherapy session).

Stimulation Matrix.

FIG. 3a shows an embodiment of a stimulation matrix 14 comprising 6stimulation pads 16 on a flexible backing 51 realized using anelectrically non-conductive substrate. In embodiments, the stimulationmatrix 14 is realized using a re-usable assembly of electrodes each withconductive hydrogel pad 16 for contacting a patient's skin anddelivering electrical stimulation. The stimulation pads 16 haveconductive material that provides the stimulation signal to a user'sskin and can also be termed “electrodes” or “electroconductive pads”.The skin-side view of the matrix 14 is shown on the left side of thefigure with a first set of 3 pads on its top half (properly located moreproximally along the limb when the system is oriented correctly) and asecond set of 3 pads on its bottom half (property located more distallyalong the limb). Each set of pads is arranged in a geometric formationhaving a mathematical triangular envelope defining a triangularconfiguration with the apex of the two triangles residing at proximaland distal ends of the matrix 14, respectively. When secured to theuser's leg below the knee the top half of the matrix 14 is closer to theknee and bottom half is closer to the feet. When a stimulation matrix 14is secured to a user's limb such as a user's arm for treatment of armpain or for modulation of arm nerves (e.g., median, ulnar, radialnerves) for treatment of unwanted medical symptoms/conditions, then thetop half is closer to the shoulder and bottom half is more distallylocated and closer to a user's hand. The three stimulation pads 16 ofthe top half each have an electrical conduit 54 a, 54 b, 54 c thatroutes stimulation signals to these from a hub 56 which in turn travelsthrough the backing 51 and connects with a stimulation matrix connector62 a at the top side of the matrix. Alternatively, signals can be routedto pads individually without the use of a hub, or a single hub can beused for all pads of the matrix 14. In the shown embodiment, the topstimulation matrix connector 62 a is a proprietary design containing 3male plugs that route electrical charge and mate with a connector (notshown) having 3 female receptacles that are provided on the bottomhousing of the neurostimulator 12. A portion of either connector 62 a or62 b may be magnetized to improve connection to the bottom housing ofthe device 12. The connectors for the lower half of the matrix (whichcorrespond to those of the upper half) are not labeled as 54 d, 54 e, 54f to avoid cluttering of the figure and are connected to the bottom halfstimulation connector 62 b. Labeling 64 which may include the words“top” is located opposite to the matrix connector 62 b to provide theuser with a visual marking that guide correct connection/orientation ofthe stimulation matrix 14 to the device 12. In an alternativeembodiment, the top and bottom stimulation matrix connectors 62 a, 62 bmay be shaped, or oriented, to require that the matrix 14 is correctlyoriented when connected to the neurostimulator device 12 (i.e., forminga “keyed” connector as shown in FIG. 1c ).

In embodiments, the matrix 14 uses stimulation pads 16 created using aconductive hydrogel or metal alloy. Pads can be used withelectroconductive gel or can be a “dry electrode” for transcutaneouselectrical stimulation. In an embodiment, the matrix is formed with aconductive backing layer having stimulation pads 16 residing on theconductive backing layer which are configured to make skin contact anddeliver electrical stimulation from the conductive backing to the skin.The stimulation pads 16 which contact the skin can be made of polymer,plastic, or rubber material with a conducting material typicallyprovided evenly throughout and having a thickness of between 1 mm and 10mm. The conductive material can be loaded with single wall carbonnanotubes or other conductive substrate.

In an embodiment, the stimulation matrix 14 is a hydrogel electrodearray assembly having 6 stimulation pads 16 having a size and shapesuitable to be applied on the skin of the medial surface of the leg overthe SAFN and supplied with stimulation signals configured to improve thechance for obtaining desired characteristics of the vector stimulationfield such as being of physical dimensions that are well suited for auser's leg and: a) are sufficiently narrow, and not wider thannecessary, to decrease the risk of unwanted stimulation of calf-muscleor non-saphenous nerves; b) are sufficiently wide to provide asufficient range across which a field's location may be controlled tosuccessfully obtain nerve recruitment; and, c) are of sufficient lengththat the pads are separated enough to create a field with an adequatedepth to stimulate the subcutaneous target nerve. Additionally, the pads16 are of sufficient size to provide comfortable and safe currentdensities and deter the risk of unwanted cutaneous nerve activation andsensation of pain/discomfort. The matrix 14 is realized with each padcomprising silver-electrodes on a flexible PET substrate, covered by anadhesive hydrogel layer that reduces electrode-skin impedance andtypically includes adhesive to promote connection to the user's leg. Inembodiments, the matrix 14 is realized using stimulation pads 16arranged in a defined geometric pattern each of which may operate asactive, return, or ground and may be independent current sources thatpermit user control over the stimulation field geometry. In anembodiment, at least 3 pads are used corresponding to at least 3stimulation channels.

In embodiments, the stimulation matrix 14 is re-usable and permits alimited number of treatment sessions. Sessions can be tracked andlimited to a permitted amount by the matrix management module 49 of theneurostimulator 12 one or more user devices 20. A connector 62 a on thetop side of the matrix 14 engages a connector portion 34 a on the bottomof the stimulator housing and provides an electrical interface with thestimulation channels of the stimulation module 42. As shown in FIG. 3A,the connector 62 a also includes an electronic ID chip 37 that thesystem 10 a uses to: a) confirm that the matrix is an authorized productof the company: b) track the number of times the matrix has been used;and, c) obtain the date of manufacture to ensure the matrix is not tooold. The ID chip 37 can contain memory storage and the matrix managementmodule 49 can read and/or write a parameter value associated with thenumber of stimulation sessions (or days) the matrix has been used. Thesystem can read/write a valid or stale “flag” value in the chip 37 or inother memory structure of the system, depending upon usage criteria. Thematrix management module 49 of the device 12 is configured to read andassess the ID chip 37 and disable the device or the matrix 14 if aspecified usage criterion is met (number of valid treatment sessions,maximum interval based upon date of first use, etc.), or present amessage to a user, or send (or prompt the user to authorize the sendingof) a purchase request to a remote computer 20 f to cause a new matrixto be purchased and shipped to the user. The usage criteria can beassessed based upon data stored in the ID chip, the neurostimulator, theuser device, or a remote computer 20 f.

In embodiments, flexibility of the matrix pad 14 is improved byproviding gaps/slits 60 b along the outside areas of the backing 51 thatallow it to bend and conform to the contour of a limb to which it isapplied. The backing 51 has alignment slits 60 a which can beasymmetrically or otherwise shaped or located along the circumference torequire correct alignment between the backing 51 and the device bottomhousing 24 b. Only one edge of the stimulation matrix or matrix 14 mayhave an alignment slit 60 a that engages a peg of the device housing(not shown) to provide correct orientation of the stimulation matrix 14.

In an embodiment, the predetermined arrangement of the stimulation pads16 of the stimulation matrix 14 includes defined angles and spacingbetween 3 or more stimulation pads that define 3 stimulation circuits.In one preferred embodiment the matrix 14 includes an upper set of 3stimulation pads 16 on its upper half, and a lower set of 3 pads on itslower half. The upper set of pads 16 has horizontal offset between padedges or centers (but not necessarily be in a triangular arrangement). Alower set of pads can have a similar arrangement, or the two sets ofpads may have different inter-pad spacings.

In a further embodiment shown in FIG. 3a , the top half of thestimulation matrix 14 is realized using at least two rows of pads 16,with a central pad that is horizontally offset (overlap) such that thereis horizontal overlap with the adjacent pads of a lower row. Thisarrangement is termed an “overlapping triangle” configuration. Thecenter pad of the first row is vertically offset in relation to theadjacent left and right pad that form the base of the triangle. A padarrangement provides adjacent pads that are diagonally offset from eachother to form a triangle (with one pad at the apex and the other 2 padsforming the base) provides advantages of: a) a reduced width stimulationmatrix 14 relative to that which results when all 3 pads are alignedhorizontally and located along the same row; and, b) the combination ofhorizontal overlap of adjacent pads and vertical offset that covers alarger area than a single row increases the chance for nerve recruitmentcompared to that which occurs with 3 pads on the same row. Theoverlapping and narrowing design may be extended to rows with anadditional number of rows or pads (e.g., 3 to 5 pads). While astimulation matrix design may also incorporate rows having more than 5pads, this may increase complexity of use and cost of the manufacturingof the matrix 14.

Although many stimulation montages are possible using 6 channels ofstimulation (any of which can serve as anode or cathode or inactive at aparticular moment in time), an advantageous strategy is to utilize a setof 3 stimulation circuits, each arranged vertically between the top andbottom portions of the stimulation matrix and include the 2 leftmostpads, the 2 center pads, and the 2 rightmost pads.

An extracorporeal stimulation matrix with fixed stimulation padpositions and electrical field steering has not previously been createdto the knowledge of the inventors. When field steering is realized incombination with using a stimulation matrix comprising a three pad“triangle” configuration several advantages are realized. First, thesize of the matrix pad can be decreased to that realized withidentically spaced rows of pads since the top pad of the triangle's apexand the bottom pads of the base row of the triangle are offset so padsof adjacent rows have horizontal overlap. Secondly the triangularconfiguration allows for adjustment of the location of the stimulationfield along both the horizontal and vertical axis of the matrix. Forexample, the stimulation montage shown in FIG. 6b produces a longervertical field, than FIG. 6h (white=“active”/grey=“inactive”). Further,relative to FIG. 6h , FIGS. 6i and 6j produce fields that verticallyextend lower, and higher, respectively. The use of only 6 pads,configured in two sets of 3, each with a triangular geometry, allows forleft/right and up/down spatial adjustment of the stimulation field.Diagonal circuits provide additional field geometries to those realizedwith strictly vertically oriented activation patterns. Diagonalstimulation fields may increase the chance of entraining a nervetravelling up the leg along the axis and that is not directly under anyof the activated stimulation pads. Examples of diagonal stimulationcircuit are shown in FIGS. 6d and 6 e.

The combination of: a) an arrangement of two sets of stimulation pads ofa stimulation matrix, with each set having a fixed triangular geometry;b) use of field steering; and, c) proper anatomical placement of thestimulation matrix as guided by detailed instructions provided to a userusing both video and text support, provides the stimulation matrix 14with advantages of: i) a reduced footprint compared to non-overlappingpads; ii) provision of adjacent stimulation circuits that have increasedchance of vector overlap by adjacent stimulation fields, and iii)improving the ability of the stimulation matrix to be used with subjectshaving a larger range of lower leg circumferences (and lengths) whileproviding an improved chance of reliably delivering therapy to a targetnerve.

The stable geometry of the stimulation pads of the stimulation matrixcan provide improved control of vector stimulation to that which wouldbe achieved with a set of conventional stimulation pads connect by wiresand manually arranged by a user. The fixed matrix may provide bettertargeting of beat or other vector fields at a target nerve due to astable, repeatable geometry of stimulation being applied at the skinsurface.

The inventors also evaluated a non-overlapping linear arrangement ofpads, where the middle pad was not offset, and 3 pads formed a singlerow. Not to be limited by theory, the triangular overlap arrangementappears to have the following advantages: a) was preferred by subjects,b) may decrease the risk that a nerve will lie between the stimulationfields created by pads arranged with “horizontal” gaps between the pads,c) increases the vertical range of the stimulation field which increasesthe chance that the field will intersect a branch of the target nerve,relative to using a single row of pads that may be below a portion ofthe target nerve, and d) decreases the width of the matrix. A widermatrix 14 will extend further around the leg circumference and providedisadvantages because it may: a) increase the risk of recruiting muscle,b) target other nerves in the leg in addition to the SAFN which maylimit tolerable amplitude or cause foot motor activity, and c) provide aworse fit for people with thinner/smaller legs. When a single top andbottom row was tested on a group of subjects disadvantages were observedsuch as less reports of robust nerve recruitment and increased reportsof self-reported calf-muscle activation, discomfort, and spasm. Someother arrangement such as a single row, or two rows of pads linearlyarranged on each of the upper and lower matrix portions offer some typeof advantage for field steering or shaping (e.g., an array of manysmaller sized pads to provide a more granular control of a stimulationfield). However, when using sets of 3 stimulations pads 14 on the topand bottom, an overlapping design appears to hold advantages.

In an embodiment of the matrix 14 shown in FIG. 3a , the top set of padsis realized using 3 pads each of which has about 1.0 to 1.5 squareinches of electroconductive surface, realized as a rounded rectangular,square or somewhat circular contour. In an embodiment, the matrix pad 14is realized as a disposable component of the system. The flexiblebacking is made of Polyethylene terephthalate (PET) or Polyimidesubstrates, printed silver, dielectric insulation and the pads made offoam, non-conductive and/or conductive hydrogels, Hydrogel and scrimassemblies which can be constructed as hydrogel formed dots or padsconfigured on a scrim of finely woven, nonconductive mesh of polyester,nylon, polyamide or similar material.

In an embodiment, the matrix 14 is realized as an upper and lower halfwhich are formed separately, and independently connect to theneurostimulator 12 so that each half can be independently replaced toreduce the cost of replacing the entire matrix 14.

While not being limited by theory, although the stimulation matrix mayhave many more stimulation pads (e.g., 10, 50, or 100), a peripheralstimulation wearable device which is configured for the arm or legrealizes many of the benefits and therapeutic efficacy disclosed hereinwhile preferably using a first stimulation array that is not more than 3pads and a second stimulation array that is not more than 3 pads. In thestimulation of the SAFN, this suggests that stimulation matrix designsthat are cost-effective and not overly complicated to use are preferablyrealized using 6 (i.e., 2 sets of 3), 7 (see FIG. 7c ) or 8 (see FIG. 7b) pads, and not more than and 18 (i.e., 2 sets of 9) stimulation pads.The cost and complexity stimulation matrix designs using a larger set ofpads may be merited when sensing or other features are incorporated.

FIGS. 4a-4d show 4 patterns for the stimulation pads 14 a-14 d whichwere assessed in a group of subjects. One part of the assessmententailed determining if the movement of the field location from the leftto the right side of the pad surpassed the subject's just noticeabledifference (JND) threshold for detecting the change. Another part of theassessment included asking about the comfort of the perceivedstimulation and ability for subjects to detect SAFN recruitment. Thefirst pattern shown in FIG. 4a was assessed as preferable since itallowed subjects to more easily feel the movement of the location of thestimulation field related to 3 different zones (left, center, and right)and also allowed them to provide a clearer confirmation of nerverecruitment. FIG. 4b shows an alternative embodiment with the top andbottom halves of the stimulation matrix 14 b having a different numberof stimulation pads (i.e., only 1 stimulation pad on the bottom half and3 pads on the top half). Stimulation with this configuration may berealized with the bottom pad serving as one anode channel whichcompletes a circuit with one or more of 3 cathodes, or vice versa. Thismore minimal design also allowed for field steering, but had thedisadvantage that the movement of the field was not as evident to somesubjects and the SAFN recruitment did not occur as reliably according totheir subjective reports. Further, when the single pad was used as ananode, this suffered the disadvantage that it produced anode dominatedstimulation and the stimulation was mostly felt under that pad, likelydue in part to the larger current density at the anode. Accordingly,this matrix design might necessitate the need for increasing (e.g.,triple) the size of the anode surface area to prevent “anode domination”(i.e., the subjective sensation being dominated by the sensation nearthe anode) and would result in coarser field steering than that obtainedusing the design of FIG. 4 a.

FIG. 4c shows an embodiment where the stimulation pads of thestimulation matrix 14 c are larger and closer together than in FIG. 4b .This design, with decreased space between electrodes, also appeared tohave the disadvantage of diminishing the user's ability to perceivechanges in the location of the stimulation field when the bottomelectrode paired with any of the upper 3 stimulation pads. Compared toFIG. 4a and FIG. 4b , there is more overlap between the fields createdbetween the circuits which included bottom pad and any of the 3 pads atthe top of the matrix. Lastly circular pads were also assessed using thedesign shown in FIG. 4d , since these could potentially allow for a morecompact stimulation matrix 14 d design. This did not appear to offer animprovement in subjects' ability to confirm the movement of thestimulation field (assessed by verbal report) of the electrical field,when compared to a geometric arrangement consisting of the roundedsquare pads (FIG. 4c ). An advantage of the invention is to usestimulation parameters and matrix characteristics (e.g., the horizontaloffset of adjacent pads, space between the pads) that permit a majorityof users to perceive a change in stimulation field's location whenadjacent circuits are selected. It is likely that pads located onadjacent rows should have less than 50% overlap to allow users todistinguish horizontal movement of the field.

The stimulation matrix design may be influenced by several potentialtradeoffs between increasing the compactness (e.g., overlap of pads) orcomplexity (e.g., using many pads) of the arrangement of pads on amatrix and increasing “reliability” for at least: a) the ability of auser to discriminate between different field steering settings; and, b)successful or robust recruitment of the SAFN. A design that is toocompact may also increase the risk of electrical shorting between padsas the edge-to-edge distance of adjacent pads is decreased. Not to belimited by theory, to avoid shorting the smallest edge-to-edge distancemay range between 0.1 and 1.0 inches, and preferably about 0.1 to 0.3inches, but should typically not be less than about 0.1 inch. Whenapplied to the lower leg, the stimulation matrix pad width is about3-inches, and the height (cephalocaudal axis) is about 6-inches. In anembodiment, three different sized matrix pads are used to accommodate alarge proportion of the population, and are 75% and 125% of the heightand/or width dimensions shown for the pad in FIG. 4e . The stimulationmatrix 14 may be provided as a single portion or as two halves which areindependently secured to the bottom of a housing of the neurostimulatordevice 12.

While the examples shown in FIGS. 4a-4e used 4 or more stimulation pads,in embodiments, field steering may be accomplished using a set of only 3stimulation pads. While this design could be used with the features ofthe invention, it was not tested. However, it would likely be preferredless by subjects similar to the reasons already discussed. A minimum setof pads that will enable field steering can comprise 3 stimulation padswhich are realized, for example, as 2 cathodes which are horizontallydisplaced with respect to the axis of the limb, and positionedproximally to 1 anode. In this example, field steering may occur byselectively and fractionally activating a combination of the 3 pads,where the amplitude of the signal between cathode 1 and anode 1 for a100 mA signal is set to 90% (90 mA) and the signal between cathode 1 andanode 2 is set at 10% (10 mA). When two pads are referenced to a commonstimulation return pad then the two stimulation source pads can each bedriven by outputs of a stimulus generator while the common stimulationpad is connected to the return side of both stimulus generators, and thetissue between each channel serves as the two loads of the electricalcircuits. In an embodiment, using the weights defined by a look-up tablewill assign a greater weight value for the first cathode or the secondcathode to determine if the stimulation field is located more on theright or left side of the stimulation matrix.

Neurostimulation Protocols and Programs

FIG. 3a shows a stimulation matrix 14 which has 6 stimulation pads whichmay be assigned to serve as a cathode, anode or inactive channel. Whenrestricting the provided stimulation to the top 3 pads the number ofpossible permutations of different channel combinations is manageable(e.g., left pad is anode and right pad is cathode; left=anode andcenter=cathode; left=anode and center and right pad=cathode, etc.) andmay be under twenty. However, if the different channels can usedifferent amplitude weighting values (e.g., left pad=100 mA (Anode),center pad=70 mA (Cathode) and right pad=30 mA (Cathode)) then thenumber of possible combinations becomes very large, even whenrestricting to a few different sets of weights. Further, if the set oflower 3 pads is added to permitted stimulation protocols then the numberof combinations grows to be unmanageable. Adjustment of stimulationparameters by a patient (or even a doctor) can become too complicatedand time consuming to be practical. Providing unconstrained freedom inadjusting the stimulation protocol cause many problems.

The SaphLocate feature of the invention uses a limited number ofselected stimulation montages that are adjusted or selected by controlsand methods to enable users to assess different candidate stimulationmontages in a simple, user-friendly, and time-efficient manner.

SaphLocate permits the location and shape of the stimulation field to beeasily and intuitively adjusted by a user and for a limited number ofcombinations of active channels to be assessed. In embodiments, oneSaphLocate program will only permit the location of the stimulationfield to be adjusted along the horizontal axis of the stimulation pad.SaphLocate can also provide the user with a limited number of candidatemontages related to adjusting the depth of stimulation.

In embodiments, the SaphLocate feature also provide adjustments to thestimulation field according to settings which are designed so that useradjustment to field location meets a sensory criterion such as a) beingperceived by the user or b) being devoid of large perceptual jumps inintensity. For example, the montages associated with providing differentfield locations are set to be above the just noticeable difference of atleast 50% of a group of subjects.

The SaphLocate features enables users to compare candidate stimulationmontages and select a preferred montage for treatment. The preferredmontage can provide at least one advantage such as improved nerverecruitment, improved comfort, or decreased risk of unwanted stimulationof non-target tissue such as muscle. SaphLocate enables improvedselection of stimulation protocol used during treatment. When used fornon-SAFN targets, this may be termed “NiNALocate”

Additionally, the NiNA system provides SaphLevel features which enableadvantages for users when adjusting and selecting an amplitude level andwaveforms to be used during stimulation treatment. SaphLevel featuresprovide users with advantages such as a better sensory experience of thestimulation, improved nerve recruitment, and enabling higher intensitystimuli to be tolerated by a user.

Accordingly, SaphLocate and SaphLevel features provide advantages of,for example: a) a limited set of stimulation montages, b) stimulationmontages that provide improved sensory experiences to users, c)stimulation montages that provide improved targeting of a nerve, d) adefined series of stimulation montages that define a how the currentstimulation montage is followed by a subsequent montage, e) a definedseries of montages with weighting values set to permit a smoothperceptual transition of the a characteristic of the stimulation fieldsuch as shape or location.

The SaphLevel™ features of the invention provide advantages with respectto adjusting the intensity level of a stimulus and its correspondingsubjective experience and ability to modulate a target nerve. TheSaphLocate™ features provide advantage with respect to adjusting thelocation or geometry of the stimulation field. SaphLevel and SaphLocatefeatures may use similar weighting values and strategies, but forachieving different advantages.

The SaphLocate and SaphLevel features of the system may both rely, atleast in part, on technologies that allow the field geometry, location,and intensity settings to provide improved therapy or improved patientexperience in relation to: a) providing limited and targeted adjustmentof the stimulation field location and geometry during initial assessmentand selection of candidate stimulation fields which can be subsequentlyused during provision of therapy; b) enabling easy user assessment ofdifferent stimulation fields during this initial adjustment; and c)providing advantages for the stimulation field used during the treatmentsession related to improved comfort and nerve recruitment.

In an embodiment the limited set of stimulation montages includesdefining a set of 3 pairs of active channels defined as left, center,and right, and assigning weights to each of the three circuits thatpermit the stimulation field to transition in a distinguishable andsmooth manner with respect to the perceived strength of the stimulationfield, from the left to the right region of the stimulation matrix.

When the stimulation is largest at the center pair of channels thenthose are considered to define the “primary channel” and the Left andRight channels are non-primary. In general, the primary channels arethose with the largest amplitude (i.e., highest weights) and the“non-primary” circuits or channels are assigned lower weights or areinactive. One of the SaphLevel features is to provide lower weights atnon-primary channels to produce at least one advantage over what wouldoccur if the non-primary channels were simply deactivated.

In embodiments, SaphLocate controls only permit the location of thestimulation field to be adjustable along a left/right axis of thematrix. In an embodiment, the adjustment along the left/right axis isprovided using a limited series of stimulation montages that have beenshown to enable recruitment of a target nerve such as the SAFN in groupof subjects or that have been shown to enable smooth and discernibletransitions between montages. Additionally, the series of montages canalso have a set of predefined allowable transitions between adjacentstimulation montages (i.e., the user cannot “skip” a pre-definedstimulation montage—and corresponding set of channel weight values—as isdefined in a series of at least 3 adjacent montages defined in a lookuptable). In an alternative embodiment, two “diagonal” montages are alsoprovided in the limited set of stimulation montages which use twostimulation channels selected from different columns of the matrix. Inan embodiment, SaphLocate does not include montages with stimulationcircuits that are approximately horizontally oriented fields which areseparated by less than a selected distance since these will havecorresponding field paths that are typically shallower.

In embodiments, the stimulation signals are adjusted using theSaphLocate features of the system that improve a user's ability tocompare and select stimulation protocol settings related to geometry ofthe stimulation field provided by the matrix 14 through the user's skin.SaphLocate features include: a) adjusting the shape of the stimulationfield by changing the geometry of active stimulation channels providedby a limited number of arrangements of stimulation pads during therapy,b) steering the stimulation field by changing the geometry/and or theamplitude and/or designation (anode/cathode/inactive) status of apre-determined set of montages for the stimulation pads, and c)providing stimulation intensity settings that are “weighted” for eachgeometry of a set of stimulation geometries so that transitions betweendifferent combinations of active stimulation pads, and correspondingmovement of the stimulation field, occurs smoothly without unwantedjumps in actual intensity or perceived intensity.

In embodiments, the treatment uses stimulation settings with variousSaphLevel features that provide advantages when determining settingsrelated to stimulus intensity and nerve recruitment. SaphLevel featuresinclude a) guiding a user to select stimulation intensity levels thatsufficiently recruit the target nerve but are below a level which ispainful to a user, b) reminding the user to re-adjust the intensity partway through the treatment session to compensate for any adaptation thatmay have occurred and which can allow the stimulation to be set higher,c) providing stimulation intensity settings that are “weighted” for aselected matrix geometry so that the sensory experience of thestimulation is “richer” and potentially less painful (as may bepredicted by gate control theory) and, d) additional features as will bedisclosed. A “richer” perception of the stimulation as was described byusers as less sharp, “prickly”, and point specific than occurs with twochannel stimulation was provided without activation of non-primarychannels and was experienced as less “piercing” with a more roundedstimulation-induced pressure sensation. The SaphLevel features can alsoinclude guiding or surveying the user to ensure that suitablestimulation strength and stimulation channels are used. For example,questions are presented to a user to confirm the intensity of thestimulus is sufficient to modulate the target nerve, to decreaseunwanted muscle stimulation, or to improve perception of thestimulation.

Ambulatory Therapy Facilitation by SaphLocate/SaphLevel.

The SAFN is a sensory nerve and targeted stimulation will evoke asensory response devoid of a motor response that characterizes, forexample, PTN stimulation. If SAFN stimulation selectively modulates theSAFN with little or no co-activation of calf muscle or nearby motornerve recruitment, then the user should be able to be ambulatory duringstimulation treatment. This may be true even if the stimulation protocolproduces moderate or strong paresthesia. When the risk of unintendedmotor/muscle response is low, this also decreases associated risks suchas muscle tear, unwanted foot activity (i.e., contraction),uncomfortable muscle twitching, or trouble with ambulation. Similarly,the risk of losing control when using the foot to operate a gas or brakepedal of a car is decreased. Accordingly, targeted SAFN in which thefield is constrained (e.g., by field steering or by selecting anappropriate stimulation montage) to avoid/minimize coactivation ofunwanted tissue or nerve targets, can allow users to engage in activityeven while stimulation treatment is provided. Since SaphLocate andSaphLevel can help to decrease risk of unwanted muscle stimulation byallowing a better selection of the stimulation parameter, these canincrease the ability of users to provide therapy while ambulatory.

Additionally, the evaluation of sensed data (e.g., accelerometer or EMGdata) can be used to adjust stimulation parameters (e.g., decreasestimulation amplitude) by the SaphLevel algorithm if these data indicatethe user is engaging in activity above a selected threshold. Forexample, while slow walking is allowed, walking above a selected speedcauses stimulation to halt, decrease stimulation amplitude, or pause fora defined interval or until accelerometer data again shows the user isless active. Improved targeting of the SAFN which allows stimulation ofthe SAFN with less unwanted co-activation of other nerves or muscles inthe leg can be achieved by at least one of: a) field steering; b)selecting a location that does not stimulate another nerve in the leg;c) selecting a location in the leg that does not stimulate the calfmuscle; d) using two or more stimulation pads of a matrix located on themedial aspect of the leg at locations that do stimulate the SAFN but notdirectly stimulate the sural nerve, posterior tibial nerve, tibialnerve, peroneal nerve, or any of the plantar nerves; and, e) providingstimulation using two or more stimulation pads that create a currentpath that is aligned with the axis of the limb (i.e., vertically offsetso that one pad is more proximal and the second pad is more distal), andthe stimulation protocol is adjusted to provide targeted stimulation ofthe SAFN.

FIG. 3b shows a touch sensitive graphical user interface (GUI) display70 of a user device 20 a that has a default therapy session screendisplayed during treatment. In the illustrated embodiment a timer 72shows the time remaining in a treatment session using both a numericalvalue and a graphical representation of a proportion of the total30-minute treatment session time that has elapsed. While a 30-minutetherapy session is shown, session duration may be, for example, aduration between 15 and 90 minutes. In embodiments, several sessions(e.g., 1 to 3) may be scheduled in a single per day.

Virtual controls allow user control of stimulation signalcharacteristics including a “Stop” control 74 that pauses thestimulation treatment (e.g., the intensity is set to zero and the timerstops incrementing), two intensity controls 76 a,76 b include a plus “+”and minus “−” symbol that increase and decrease the stimulationintensity, respectively. Additionally, a field steering managerinterface 78 provides SaphLocate features such as a left and rightcontrol 80 a,80 b that moves the stimulation field from the left toright side of the matrix using a predefined series of stimulationmontages. Using proper amplitude weights for the stimulation montage canallow adjustment of the geometry or location of the field to occur in asmooth manner that permits user to perceive the movement of the field'slocation. A field location display 82 of five circles are highlighted asthe field moves from left to right. When worn around the upper calf thismay move the field from an anterior region near the tibia to a posteriorregion of the leg, or vice versa, depending up on the leg on which thematrix is worn. In embodiments, a SaphLocate features provide a fieldlocation display 82 on the display screen of the neurostimulator 12and/or user device 20 a to reinforce the user's perception of theadjustment of the stimulation field.

In embodiments, as will be disclosed, the field steering managerinterface 78 can be selected (i.e., double tapped) to expand to includeadditional “advanced” controls for adjusting characteristics of thestimulation field such as the horizontal or vertical center of thefield, adjusting the number of montages that are used to move the fieldfrom a first to a second location (e.g., from left to right) or allowingthe user to adjust if a set of one or more stimulation pads serves asanode, cathode, or is inactive. As disclosed, control of individualchannels may typically be too complicated for most users. However, insome instances turning off a single stimulation channel may be useful,such as making the lower right or left stimulation pad inactive toattenuate unwanted calf-muscle activation. In the case where astimulation channel is deactivated, the SaphLocate algorithm can adjustthe remaining active channels so that the anode/cathode charge deliveredfrom the matrix remains balanced.

In the shown embodiment, SaphLocate is realized with left and rightcontrols permit selection of a stimulation montage from a set of 5discrete field montages defined along the left-right axis of thestimulation matrix. Each of the 5 defined “zones” has an associatedlocation label such as: Left, Center-left, Center, Center-right, andRight. Additionally, an “All” setting causes the stimulation field to beprovided approximately with the same amplitude across all zones. In thisexample, the matrix of FIG. 3a will be used although other arrangementsof stimulation pads could alternatively be used. If the stimulation padsof the matrix 14 are conceptually arranged as rows and columns, thenthree columns of electrodes exist, and the On(1)/Off(0) status for eachcolumn created for these 5 stimulation montage and the “All” montage maybe defined in a simple embodiment as: [1 0 0], [1 1 0], [0 1 0], [0 11], [0 0 1], [1 1 1], respectively. In FIG. 3b , the user has selectedthe Center-right zone which causes the stimulation signal to be providedby 2 pads at the center (apex) and 2 pads on the right side of thetriangle arrangements of the stimulation matrix shown in FIG. 3a . Aswill be discussed, instead of 3 columns, each with two vertically offsetchannels, the stimulation pattern may be defined for pairs of diagonallyoffset channels (i.e., a circuit is made from channels selected fromdifferent columns).

Accordingly, the field steering manager interface 78 provides the userindependent adjustment of both the strength 76 a,76 b and the location80 a,80 b of the stimulation field produced by summation of stimulationsignals provided by the stimulation matrix 14. In the shown embodiment,the location of the field is adjusted along the left-right axis of thematrix 14 (i.e., perpendicular to the axis of the stimulated limb) usingonly two controls. Alternatively, the field location display of circleswhich light up corresponding to the left-right position of the field canalso be selectively activated if a user slides a finger across thecircles, or by double tapping a circle so that the stimulation field isadjusted to the field settings associate with the respective circle.

In embodiments, instead of 5 zones and the “All” setting, the userdevice 20 may be designed to provide a user with a coarser stimulationfield control (e.g., only 3 zones may be selected and only the left,center, or right columns of stimulation is activated). Alternatively, afiner resolution of adjustments (e.g., 7-10 or up to about 15-20 zones)is defined using discrete steps with weight values for each columndefined in a lookup table. When providing more stimulation zones thanthe number of stimulation columns available in the stimulation matrix,instead of simple On(1)/Off(0) status used in the above example, thecolumns are allocated weight values which represent “percentage of thetotal stimulation amplitude” (e.g., current) that results due to aweighting operation. The weighting values are used to adjust amplitudeof each column. For example, the ‘Left’ setting can be realized as [1000 0] and ‘Center’ can be [0 100 0], and a gradual shift from Left toCenter can be realized using a series of montages with correspondingweights (e.g. [90 10 0], [80 20 0], etc.).

In embodiments users can toggle between a “coarse” field control (e.g.,5 zones) and a “fine” field control (e.g., 15-20 zones) as a matter ofuser preference. Alternatively, a user can simply select the number ofzones from an allowed range (e.g., from 3 to 20). When a greater numberof zones (e.g., 15) are used instead of fewer (e.g., 5), the change inthe weighting values as the stimulation field moves from left, tocenter, to right, of the stimulation matrix is more gradual. Forexample, when using 7 zones then as the field moves from left to center,the weighting values of a circuit may change by 15% between eachadjacent zone so that the left channel weighting transitions as 100, 85,65, 50, 35, 20, and 5, while the weighting values for the centerchannels are inversely increasing, as 5, 20, 35, 50, 65, 85 and 100.However, while the transition may be smoother, increasing the number ofzones can require a user to spend more time trying to discerndifferences between montages. Not to be limited by theory, during pilotwork while some users preferred finer field steering control, thisappeared to frustrate/confuse users who had difficulty distinguishingbetween the zones and who did not seem to benefit from finer control.The number of zones and differences between zones should be sufficientthat a majority of users, or the user who is operating theneurostimulator, can feel movement of the location of the field (i.e.,at or above their JND), without finding the number of adjustments to betedious.

In embodiments, rather than using zero for any weight, the SaphLevelrules implemented by the system 10 a require weights to always be setabove a level such as 30%. Setting weights of non-primary channels tonon-zero values can have advantages during treatment stimulation suchas: a) providing stimulation at non-primary channels can cause thestimulation to feel richer, b) providing stimulation at non-primarychannels can cause improved recruitment of the nerve due to increasedenergy of the vector field at the target nerve, c) supra or subthresholdstimulation at an area of the nerve provided by stimulation of thenon-primary channels may increase the chance that stimulation from theprimary channel will result in nerve modulation, d) the amplitude of theprimary channel needed to recruit the nerve may be lower when energyfrom non-primary channels is also provided which may lead to increasedpatient comfort, and e) a higher amplitude at the primary channel may beused due to factors such as sensory masking. Additionally, the weightsused at non-primary channels can change as a function of the amplitudethat is provided at the primary channel. For example, the fall-off inweights can be larger when the amplitude of the primary channelstimulation signals is well above nerve recruitment threshold. Inrelation to SaphLocate, use of non-zero channel weights can also beuseful when the stimulation signal location is adjusted, for example,from the left to the center-left channel. For example, increasing theweight of the center left channel from 0% to 50%, is larger thanincreasing the value from 40% to 60% and the transition can be perceivedas smoother. Additionally, setting the weight at 40% rather than zeroincreases the chance that the stimulation is already above threshold, sothat the increase to 60% is causes a smaller change in neural activity,and perceived intensity, than occurs when transitioning from 0% to 50%.

Individualized Adjustment of SaphLocate Parameters

In embodiments, the number of zones (and the associated number ofstimulation montages and corresponding weight values) are selected dueto the results of an assessment procedure that occurs during onboardingof the user. For example, an assessment of a user's sensitivity to finerchanges is assessed by asking a user to press a button if they feel achange in the stimulation field location when the location is alternatedbetween two settings, as may occur with a forced-choice threshold testwhere the threshold defines the difference between the two settings. Forexample, the system may automatically move the field using a coarsesetting and then increase the number of zones and determine if the useris sufficiently sensitive to detect the movement between zones asconfirmed by a button press. Once the JND of a user is established fordistinguishing between locations, this can be used to set the SaphLocatezones parameters.

In embodiments, a SaphLocate feature adjusts the stimulation protocol sothat a) the number of montages provided to a user and b) thecorresponding weight values are both selected so the user can typically:a) perceive the movement of the field when selecting different montagesand, b) movement of the field does not occur with large changes in theperceived intensity of the stimulation.

An advantage of the invention is to provide an adjustable level oftuning for the stimulation field controller which includes at least 2levels of specificity or coarseness that may be selected by a user.

In an embodiment, the coarseness of zones may be set by selecting a“Settings Gear” control (see menu control of FIG. 9a ). This willpresent the user with options that related to therapy including controlof stimulation adjustments using a “fine” or “coarse” stimulationresolution. When clicked, a “Location Resolution” option display pushedis displaying the “Coarse” and “Fine” device control options (See FIG.3e ).

FIG. 3c shows a treatment screen 208 with the number of zones set to 15using a Fine resolution scheme. This can be realized using 15 differentweighting functions for 3 (or more) pairs of channels which are storedin a lookup table. In this example, when the field steering protocol isset to “ALL” then this includes 3 independent columns of constantcurrent stimulation where all the channels of the matrix have equalweights. The “ALL” setting is an important option since during a studyhaving stimulation montages limited to 3 vertical circuits (eachcomprising a pair of pads having a single anode and cathode), some userspreferred stimulation using “All” (more than any of the 15 montages thatmoved the field from left to right of the matrix) since this providedbetter nerve recruitment than using montages where some channels hadlower weightings, as evidenced by robust stimulation-induced paresthesiareported in their lower leg or foot with little or no musclestimulation.

FIG. 3d shows a treatment screen 210 with the field steering protocolset to center, and again there are 15 zones. In an embodiment, “center”may cause the 2 pads of the center column of the stimulation matrix tohave a weighting value of 100% while the adjacent pads of the Left andRight columns are weighted as zero (i.e., set as inactive).

FIG. 3e shows a Location Resolution screen 212 displayed by the device20, having a menu for choosing a Coarse (e.g. 5-7 zones) or Fineadjustment (>7) resolution by a user. When used by a medicalprofessional the resolution screen can allow for a more detailed controlsuch as permitting the user to select any number of zones between 5 and20 zones (and associated weightings) related to defining stimulationzones along at least one axis of the stimulation matrix. Additionally,when the stimulation field is adjustable along more than one axis, theresolution can be set differently for the x-axis (vertical) and y-axis(horizontal) of the stimulation field. If a graphical display orjoystick is used by a user to move a stimulation field along the x-axis,or y-axis, or both simultaneously, then the coarseness can also bedefined for such adjustment.

In embodiments, a “coarse” controller scheme utilizes between 3 and 9steps between the extreme leftmost and rightmost field settings, with apreferred embodiment of about 5 and a “fine” controller scheme utilizesbetween 10 and 20 steps between the leftmost and rightmost stimulationfield montages, with a preferred embodiment of about 15. These can beset differently for each axis.

FIG. 3f shows an alternative screen 214 embodiment, when more than 3columns of electrodes are provided in the stimulation matrix. In thisexample, a user may select a “narrow” or “broad” spread for thestimulation, which causes, for example, 2-3 columns (e.g., [0 0 0 90 10090 0 0 0]), or 7-9 columns (e.g. [0 0 80 90 100 90 80 0 0]) ofstimulation pads of a 9-column matrix to be active. In this embodiment,the narrow or broad set of weighting factors for a set of pads movesfrom left to right. In the figure the weightings are displayedgraphically so that the higher amplitude weights are shown with a darkercircle, and the shading is lighter as the weighting decreases. Theadjacent pads may be weighted using non-zero levels (e.g., columnsdirectly adjacent to a primary set of channels are set at 50%) or alevel of spread found to produce an advantage in the sensationexperienced by a user.

Additional Stimulation Signal Characteristics

Without being limited by theory, in an embodiment, three aspects mayserve as main determinants of the stimulation protocol that is selectedfor treatment of a target nerve such as the SAFN. The stimulation signalshould: A) be at an intensity level that causes modulation of the nervebut which is still low enough to be comfortable/tolerable to a userduring treatment; B) should be provided by a matrix of stimulation padsand stimulation montage configured to steer/shape the stimulation fieldso that it is focused on/near the target nerve for improved targeting ofthe nerve; C) have pulse characteristics that provide robust nervemodulation.

In addition to SaphLevel and SaphLocate aspects of the stimulationprotocol, the stimulation signal itself can be modified by the programto improve nerve recruitment. For example, pulse duration may beadjusted to improve target nerve entrainment. While a pulse width of 200uSec may often be used for a modulation rate in the 20 Hz range in thecase of saphenous (or other) nerve stimulation, increasing the pulsewidth to between 400 uSec and 20,000 uSec, or using a duty cycle of upto approximately 50% may produce a deeper stimulation path and greaterentrainment. The longer pulse width is also better at recruiting smallerdiameter fibers including unmyelinated c-fibers. Accordingly, a controlfor adjusting pulse width may also be provided on the control screen ormontages associated with deeper stimulation paths may be combined withlonger pulse widths as a SaphLevel feature.

User Adjustment of Stimulation Field Location and Geometry.

In embodiments, a SaphLocate feature allows different stimulationmontage settings to be assessed and compared to enable selection one ormore montages which provided improved nerve recruitment to be selectedand used by the treatment protocol. In the case of SAFN recruitment, aprotocol that provides improved nerve recruitment may be defined, forexample, as a protocol for which one of the following occurs: thestrongest perception of nerve recruitment is obtained; an evokedparesthesia changes from being a gentle tingling to a stronger sensation(e.g., vibration or thumping sensation); an evoked paresthesia is feltat the most distal location (i.e., down into the foot and to the toes ismore distal than evoking sensation only near the stimulation pads);robust nerve stimulation occurs in the absence of unwanted collateralco-stimulation, such as of adjacent muscle or other nerves; robust nervestimulation occurs in the absence of foot movement; the differencestimulation energy required to evoke skin sensation (skin sensationthreshold) and nerve recruitment (nerve recruitment threshold) is thesmallest; or, the largest amount of nerve recruitment is reported by theindividual in the absence of the feeling of pain or discomfort. Whileany of these criteria may be used, often the patient will simply beasked to choose a stimulation montage that produces a clear sensation ofparesthesia which extends as far as possible towards the ankle and/orinto the foot, while minimizing effects due to stimulation of non-targettissue. FIGS. 5a-5i show embodiments of screens provided by the userinterface module 48 that permit adjustment of the stimulation fieldprovided by a stimulation matrix 14 operating in conjunction with thestimulation module.

FIG. 5a shows an embodiment of a “Slider” field steering managementconsole 216 in which the slider control is adjusted (“slid”) from aleftmost position to a rightmost position. The user slides the barcontrol by swiping a touch display of user device 20 with a finger. Thelocation of the bar is then set in a position during therapy that wasmost preferred by the user (e.g., produced the nerve recruitment). Themovement of the virtual control on a display screen of a user device 20is accompanied by visual signaling of changes in the position of thestimulation field. For example, one or more subsets of a set of coloredcircles may show the selected region of activation in relation to fullrange of the left-right axis of the matrix. Further the “c1”, “c2”, “c3”labels at the bottom of the screen can show the percentage of amplitudeapplied to each of three columns of the stimulation matrix (e.g., thoseshown by FIGS. 6a, 6b . and 6 c). The bar control can also be realizedas a physical control on the housing of the device 12 or of a userdevice 20 such as a remote-control device.

In an embodiment, as the control is slid from the left to the rightposition it travels through a series of intermediate positions and eachposition is mapped to a stimulation montage in a set of stimulationmontages such that movement of the control corresponds to sequentialselection of a series of stimulation montages. The set of stimulationmontages is configured to cause a change in the location and/or shape ofthe stimulation field in an intended manner. For example, sliding thecontrol can be mapped to cause the stimulation field to move along atleast one axis of the stimulation matrix, such as from left to right,such that the movement of the field occurs without causing transientjumps in the perceived intensity of the stimulation field.

FIG. 5b shows a “Directional” field steering management console 218 witha set of controllers realized as left and right arrows which the useroperates to directionally adjust the left-right displacement of thestimulation field. This control has several advantages. It is easier forusers lacking fine motor control as may be needed to adjust the slidercontrol. Users press the left or right control to incrementally shiftthe location of the stimulation field to the left or to the right. Ithas been found by the inventors that subjects tended to prefer a set ofabout 5 stimulation montages when spanning from left to right with thestimulation matrix design that was tested. Using an increased number ofsettings took longer for subjects to assess, did not as consistentlyprovide perceptible changes in field location by users, increased thedifficulty of selecting a preferred stimulation montage, etc. In anembodiment for stimulating the SAFN the directional control maypreferably use between 5 and 10 montages, and more preferably 5. An“All” montage may also be provided.

In an embodiment, at least one directional control is provided whichwhen pressed causes a defined movement of the stimulation field such asfrom the left to the right position. Typically, two directional controlsare provided to allow user control in a first direction or a seconddirection that is opposite the first direction. Pressing a directionalcontrol causes the incremental selection of a stimulation montage from aset of stimulation montages such that operating the controls correspondsto sequential selection of a montage from a series of stimulationmontages (with a montage characteristic such as an amplitude weightingvalue defined in a lookup table or realized through adjustment ofsettings in electronics). The set of stimulation montages is configuredto cause a change in the location and/or shape of the stimulation fieldin an intended manner in response to user input to the control. Forexample, pressing the left and right directional control causes thestimulation field to move along in a first or second direction along atleast one axis of the stimulation matrix, such as from left to right.

FIG. 5c shows another SaphLocate feature 220 of the system. In anembodiment of the “Cycle” field steering management screen, pressing the“P” button causes the stimulation module 42 sequentially adjust thestimulation field in steps through a set of stimulation montages thattransition in a determined manner. For example, the transition is from aleftmost position to a rightmost position in relation to the stimulationmatrix. The set of stimulation montages may include only verticallyoriented circuits (i.e., columns of the stimulation matrix) or may alsoinclude one or two diagonal circuits). If a position is preferred, thena user can confirm this, such as by pressing the input button labeled“P”, or the user can provide a verbal indication “use that setting” ifthe user interaction module 48 is configured to receive voice commands.The cycle may occur 2 or 3 times and the user may be required to selectthe same stimulation montage consistently for it to be selected for usein treatment. The system can then use the user preferred stimulationmontage during the provision of treatment. In an embodiment, thesequential left-right adjustment, or other adjustment of field montages,is selected using sets of weightings for each stimulation channel asdefined in a lookup table.

In the embodiment shown in FIG. 5c , the screen does not provide avisual indicator of field location comprising the highlighted circles(although the percentage amplitude being used at each of the three“columns” of the matrix is shown on the bottom of the screen). When thissignaling was removed, subjects were not as confident in reporting wherethe field was located. Providing a real-time visual indication of thestimulation field characteristics in addition to the stimulation evokedsensation perceived at the skin can a) reinforce and facilitatesubjective discrimination of field location and movement and b) allowusers to become familiar with what location setting works best for them.

FIG. 5d shows a “select” device management screen 222 with a set ofbuttons provided to correspond to the left-right adjustment of astimulation field. For example, 3 buttons can move the field from Leftto Center to Right, and this position can be indicated visually by the 3virtual oval indicators. The Select control only allowed a first subsetof the pads of the stimulation matrix (e.g., 1 of the columns of thestimulation matrix) to be selected while restricting the stimulation toother subsets of pads on the matrix (e.g., the activated subset of padswas restricted to 1 of the columns of the matrix at a particular time).In an embodiment, a set of user controls are defined with each controlassociated with a particular stimulation montage and the controls aremutually exclusive such that only one control can activate a selectedmontage and associated set of stimulation pads.

FIG. 5e shows a “Toggle” device management screen 224 for which a usercan toggle the stimulation field of each column of the stimulationmatrix by selecting one of the controls to toggle each electrode pair ofa column independently between at least ON and OFF states. Toggle canalso be implemented to provide a series of steps between OFF and severalamplitude weights (e.g., [off, 10%, 40%, 70%, 100%]). In embodiment, the“Toggle” control is programmed to be different than the “Select” controlwith the former only allowing one column to be selected at a given timeand the latter defined to allow two or more columns of stimulationmatrix to be adjusted. If toggle allows for multiple weights to be used,the brightness of the circles used on the display to indicate On/Offstate, can also be shown as larger or brighter when the weighting factoris larger.

In an embodiment, a set of at least one toggle user control is definedso that the control adjusts the on/off state of a selected set ofstimulation pads. In an alternative embodiment, the toggle user controlsadjusts both the state (On/Off) and also the amplitude weighting of aselected set of stimulation pads. In an embodiment, the set of toggleuser controls includes at least two user controls and the controladjusts the state (On/Off) or characteristic (e.g., amplitude weight) ofat least a first and second set of stimulation pads, and toggling the atleast two user controls is not restricted to be mutually exclusive.

FIG. 5f shows a “L-R Slider” device management screen 226 realized asthree 3 slider controls, each of which controls a characteristic such asthe amplitude if a set of stimulation pads such as a column of thestimulation matrix. These may be slid by a user to adjust thecharacteristic value to be set at a value within a defined range (e.g.,between 0 to 100) to cause the stimulation field to be adjusted such asfor the stimulation to occur on the left, center, or right region of thestimulation matrix. In embodiments, if the stimulation matrix has morethan 3 stimulation columns defined for the stimulation matrix then useof sliders for each column becomes cumbersome. Additionally, thisembodiment can be difficult since, like Toggle and Select screens a usercan provide stimulation on the left and right matrix regions but not thecenter. This produces two discrete areas of stimulation and increasesthe complexity of selecting a field compared to the Directional screen.

“Toggle” was preferred by some users because it permits toggling thestate of multiple columns to occur simultaneously, gave users morecontrol than “Select”, and provided a preferable sensory experience(ostensibly since multiple columns could be simultaneously activated).However, “Toggle” as discussed, introduced a user interface challengedue to multiple combinations of the 3 On/OFF buttons that was furtherincreased when the buttons allow toggling between OFF a few intensitylevels. Even using ON/OFF for 3 sets of channels could frustratesubjects. Select” forced the user to choose from only one column of thematrix (radio style). Users liked it because it was simple to implement,but did not provide the best sensation and may not have recruited thenerve as well. These considerations supported using the Directional userinterface having ease-of-use associated with “Select” with the abilityto use 5 stimulation montages that weighted more than one column andallowed adjustment of the stimulation field simply by pressing the twoDirectional controls.

In an embodiment, 5 zones define the steps for moving along theleft-right axis of the matrix. The corresponding labels are (orindicate) Left, Center-left, Center, Center-right, and Right. An ALLsetting is also provided where all 3 circuits are set equally, such asat 75%-80%, or at 100% (although 100% can result in an uncomfortablestimulation intensity that is too strong when transitioning from 1 or 2circuits, since all 3 circuits provide energy). Alternatively, thecenter pad circuit is set at 100% and the pads of the left and rightcolumns are set slightly lower (e.g., above 80%). Or only the left orright column has a lower weight value, for example, to avoid stimulationof muscle. If instead of Left and Right, the terms “Towards shin” and“Towards calf” are used in the software of the App 21, then this isswitched depending upon which leg the user has indicated is being usedto provide treatment.

When operating the system according to the above field-steering methods,the stimulus intensity can be initially set by a user in a locationsetting (e.g., Left) using intensity control buttons to select a strongstimulation level that is below a user's pain threshold. AfterSaphLocate has been used to assess the different field steering settingsand select the stimulation montage that will be used during treatment,the user may then adjust the intensity setting to be higher or lower toprovide comfortable stimulation levels during therapy.

While the field steering controls just described provide advantages thatare most evident when using a stimulation matrix having 3-5 columns,other controls may offer advantages when a greater number of stimulationpads are used in the matrix or if more complicated stimulation montagetemplates are used. FIG. 5g shows an alternative embodiment of a“Slider” management screen 228 having 3 different slider controls. The“Position” control adjusts the position of the amplitude maximum and maybe set to control the field in the left-right axis of the stimulationpad, the “Spread” control adjusts the number of adjacent pads that areactivated, and the “Fall-off” control adjusts how sharp the fall-off ofweights are from the position of maximum amplitude. When used incombination with a stimulation matrix such as that shown in FIG. 7d ,the Position control may adjust the column or columns (e.g., 4 and 5)where the stimulation circuit having the maximum stimulation occurs, theSpread control adjusts the number of adjacent columns which also provideactive stimulation channels (e.g., 2-3 and 6-7), and Fall-off controlincreases the fall-off of the amplitude weights across channels as theybecome more distant from the maximum channels (e.g., 2 (85%) and 3(60%)).

FIG. 5h shows an alternative embodiment of a “Directional” devicemanagement screen 230 having a directional “joystick” controller, aswell as Spread and Fall-off controls. As shown in FIG. 7e , a definedstimulation montage in the upper side of the matrix provides anodeguarded stimulation using 3 cathode channels (C1, C2, C3) distributedacross 3 stimulation pads surrounded by 10 anode channels. The joystickcontroller can adjust the location of the arrangement of active channelswithin the stimulation matrix. The Spread control adjusts the number ofactive channels in the left-right axis of the matrix (e.g., using 1 to 3columns of cathodes), and the Fall-off control adjusts how discrete thestimulation field is by setting the fall-off of the magnitude of theweightings away from the primary stimulation channel(s). In an example,where the joystick set the primary channel near the center of the matrix(left-right axis) then “C2” and “A2” would have relatively higherweightings than the anodes and cathodes that flank it to the left andright as the Fall-Off parameter was decreased. In addition to pads thatare directly adjacent to the cathodes, anodes may also be provided atnon-adjacent pads that are separated from the cathodes by at least oneintervening pad. In further embodiments, the user may be able to selectseveral stimulation montages of various preset shapes and the joystickthe permits these to be moved to different locations within thestimulation matrix. In the stimulation montage in the lower half of thematrix, the spread parameter has been decreased so that the stimulationfield has less spread (along the left-right axis). In embodiments, theSpread and Fall-off controls can be provided to adjust the field alongmore than one axis.

FIG. 5i shows an alternative embodiment of a stimulation montage fieldcontroller screen 232 which includes a touch-pad controller that allowsa user to adjust the characteristics of the stimulation field usinggestures such as “dragging” a shape with a finger in a direction toadjust the location of the field within the stimulation matrix. Othergestures such as pinching the shape will decrease the spread of thestimulation field, or spreading two figures away from each other willwiden the stimulation field. The gestures are tied to algorithms thatmake corresponding adjustments to the stimulation field by activatingadditional stimulation channels, deactivating stimulation channels,adjusting the weights of activated channels, moving the location of aset of active channels to a different position on the matrix, orselecting a montage from a defined series of montages that correspondsto the adjustment.

In embodiments, virtual stimulation maps provided by the virtual module50 a of the digital ecosystem module 50 permit users to control thestimulation module to spatially steer the stimulation field in 2D or 3Dspace. For example, users may adjust the location and shape of an imageof the stimulation field which is presented on a grid or on a model of aleg. The user may “drag” the centroid of the field to a desired locationand may “squeeze” or “push” the field away from a particular area. Thedevice can adjust the stimulation in real-time according to the user'sgestures, which are translated to corresponding stimulation parameters.For example, having a user drag the centroid of a stimulation field tothe right on the display of a smartphone will lead to a correspondingshift of stimulation energy to the pads on the right side of the matrix.If a user squeezes a field or pushes a virtual button that correspondsto increased depth, then this may be accomplished using “guarding” or byactivating electrodes with larger inter-electrode distances (which canincrease field depth).

The SaphLocate features of the disclosed invention provide an advantageof allowing users to adjust the stimulation field characteristics inintuitive, user friendly manners that utilize pre-defined sets ofstimulation montages, and series of stimulation montages, that may beselected or adjusted in a limited number of manners. This is preferredto requiring users to attempt to adjust stimulation parametersindependently for each channel or for many possible stimulationcircuits.

Lastly, FIG. 5j shows an “advanced” screen 234 that may be provided bythe user interface module 48 to users with selected permissions, such asa doctor. It may only be provided on certain user devices such as adoctor computer 20 c. In embodiments, controls are provided to enableusers to select “paresthesia absent” or “paresthesia present” as well aswhere it occurred “toes” and these inputs are stored with the montageprofile information in the log data. While the figure shows “paresthesiapresent”, the button is a drop-down menu that includes other options, inthis case “absent”. Users can also indicate problems that occurs with aselected stimulation montage such as “muscle stimulation”, “pain”,“discomfort”, or other side effects. The log information for a series ofmontages can be displayed in a table and information can be reviewed bya doctor to assess results. The screen also allows control of the stepsize of the changes applied to montages. For example, weight adjustmentused to change a field location can be set (e.g., steps of 10% or 20%).The size of the changes in amplitude can also be set (e.g., amps). Inembodiments, the montage may define stimulation signal pulse duration(e.g., 2000 uSec) of the primary channel to be different than (e.g.,longer) than those provided at non-primary channels. That may increasethe chance for the nerve under the primary channel to receive relativelymore stimulation than occurs for sideband channels, and decrease riskfor stimulation of adjacent muscle or nerve tissue. For interferometry,montages can be set different channels with different pulse rates orpatterns. In embodiments, in addition to moving the location of thefield, a button control with a drop-down menu is used to bias the fielddirection to the “left” or “right”, at a minimum, but may also controlbiasing in a “proximal” or “distal” direction or to increase depth. Thevirtual field provided by the montage can be calculated by the virtualmodule 50 a and displayed to a user. In embodiments, if a userdeactivates a channel, such as to avoid muscle stimulation, then thestimulation module 42 will distribute the associated cathodic or anodiccharge across the remaining active pads.

Automatic Adjustment of Stimulation Field Location and Geometry.

The system permits user selection of a stimulation montage to be usedwith selected stimulation matrix such as that shown in FIG. 3a . Inembodiments, the system 10 a also supports curated procedures forassisting with this selection. In an embodiment, a SaphLocate assessmentprotocol includes one or more of the following steps if a user selects aprogram button “P” as shown in the field control screen of FIG. 5 c:

A) Ramp stimulation amplitude on two or more active channels. Obtainuser input (e.g., button press) that flags at least of the followingsubjective measures for the user: skin sensation threshold, nerverecruitment threshold, level of strong but tolerable sensation, level ofdiscomfort (e.g., a level believed to be unbearable for 10-30 minutes ofstimulation), level of painful onset (e.g., a level that would bepainful even for several seconds). At the end of the ramp, wherestrength of the stimulation signal is largest and where a user indicatesit is painful, the stimulation intensity is reset to zero or the channelis turned off. Rather than, or in addition to, subjective measures, anobjective measure such as SNAP can identify nerve recruitment threshold.B) The ramp protocol is done for channel set #1 (e.g., C1 to A1, of FIG.6a ; active channels are unshaded) and then for each of the sets ofchannels defined for the remaining columns of the matrix moving fromleft to right or in random order (e.g., stimulation channel set #2 (C2to A2 of FIG. 6b ); and channel set #3 (e.g., C3-A3 of FIG. 6c ).C) The ramp protocol is done for each stimulation montage (andcorresponding weights) for a set (e.g., 5) of candidate stimulationmontages moving from left to right or in random order.D) The ramp protocol is done for “All”, which includes all columns ofthe matrix.E) The ramp protocol is done for two diagonal stimulation montages suchas C1-A3 of FIG. 6e or C3-A1.F) This ramp protocol is done for each individual circuit (e.g., C2 toA1, then C2-A2, then C2-A3) of a stimulation montage which may be usedduring stimulation (e.g., the full montage is one cathode used inconjunction with 3 anode contacts (the combination of C2 to A1, and A2and A3).G) This ramp protocol is done for independent circuits of a stimulationmontage (e.g., C1 to A2, and C2 to A3 of FIG. 6k ) at the same time orsequentially.

Since all 6 of the stimulation pads of the matrix can operationally beset as an anode or cathode, the set of potential “channels” combinationsthat are assessed should be done in a limited manner due to the largenumber of possible permutations. The “programming” process should bedone “intelligently” to provide a practical algorithm that only assessespermutations that are related to a limited set of selected stimulationmontages. In a preferred embodiment, steps C and D occur and thestimulus montage that had the lowest nerve recruitment threshold isselected for treatment.

The results of this ramp assessment can be stored in a lookup table anddisplayed to a user (as a table or heat map for any of the sensationmeasures obtained in step “A”) such as the patient or medicalprofessional. In embodiments, the stimulation pad montage that producesthe highest score for a desired characteristic can be selected. Forexample, the stimulation montage which corresponds to the lowestthreshold of nerve recruitment, or the largest difference between nerverecruitment and level at which pain is experienced, can be selected by auser or by the SaphLevel algorithm. When various pairs of stimulationpads are activated as channels, such as a pair of 2 pads from a set of 6or more pads, tables or heat maps may be used to present data to a userabout which intensity levels were related to different sensationmeasures.

In an embodiment, a field adjustment algorithm uses channel weightingvalues that allow movement from the left-to-right or from right-to-leftwhen a user presses the control buttons labeled “P” in FIG. 5c so thatdifferent stimulation of series a using activated selectively are zonesbe to configured be may This montages. perceived as moving from left tocenter to right regions of the stimulation matrix without sharp jumps inperception of cutaneous stimulation strength in the areas below thestimulation pads occurring with transitions between zones: i.e., similarperceived strength of stimulation is preferred. This enables the user toaccurately assess and compare the different montages to select apreferred montage (e.g., strongest recruitment of the target nerve whileminimizing unwanted effects of stimulation) to subsequently use duringthe provision of therapy. While weight values are adjusted to benon-zero in channels outside of the primary circuit (where stimulationamplitude is highest) during the assessment of different stimulationmontages, these non-primary stimulation channels may then be set at zerowhen actual treatment stimulation is provided (i.e., if the central twostimulation pads (e.g., C2,C3 of FIG. 7e ) are primary then the left andright circuits are zeroed). When a matrix such as that used in FIG. 7eis used, then the algorithm may move a pre-selected stimulation montageshape to different regions of the stimulation matrix.

Hardware Field Steering.

FIGS. 6a, 6b, and 6c show embodiments of stimulation montages realizedas a left-sided, centered, and right-sided stimulation field,respectively. Each column of the stimulation matrix comprises oneproximal anode (e.g., A1, A2, or A3) and one distal cathode (e.g., C1,C2, or C3). Alternatively, the top electrodes may be designated ascathodes and the lower set of electrodes serves as anode. A firstcircuit includes the leftmost pair of pads as shown in FIG. 6a(active=unshaded), while the central pair and rightmost pair areinactive. The user may also activate the central pair of pads as shownin FIG. 6b or the right most pair of pads as shown in FIG. 6c , whilethe other two pairs of channels are disconnected. This allows formovement of the field from left to center to right.

Instead of adjusting the amplitude weight values using a sequence thatis defined for each of 3 columns of a matrix, the Slider control canprovide stimulation using alternative sequence that moves the field fromleft to right by using a circuit defined with channels from two or morecolumns of the matrix. For example, the sequence which transitions fromLeft to Center can include the stimulation montages defined by FIGS. 6a,6d, 6f, 6l , and then 6 b. In other words, the stimulation montagesequence does not have to incrementally change from using 1 circuit (1anode and 1 cathode) to 2 circuits (2 anodes and 2 cathodes), whenadjusting the field from left to right. Additionally, while FIGS. 6a-6nshow the anodes on top, the cathodes can be on the top of the pad.

With respect to generation of stimulation signals that contribute toshaping of the stimulation field, the stimulation module 42 may utilizecircuit designs which use ganged arrangements of the stimulationchannels, independent stimulation channels, or mixed arrangements.

Independent Channels. In embodiments, the system is typically configuredto provide independently controlled stimulation signals to eachstimulation pad. When using a triangular arrangement of 6 stimulationpads distributed across the top and bottom of the stimulation matrix 14,these can be realized as 6 independent channels of stimulation. Thisrequires the stimulation module 42 to be capable of generating multiplestimulation channels as may be done using multiple stimulus generators,by multiplexing circuitry that can drive N channels through sufficientlyquick switching, or by other means known to those skilled in the art.

Ganged embodiments. Ganged embodiments are realized when a signal from asingle stimulation channel is provided through two or more stimulationpads (two or more stimulation pads are electrically combined).

In an embodiment, the stimulation module 42 is configured to provide orswitch between independent stimulation channels or ganged channelarrangements, or a combination (e.g., a circuit of one anode and onecathode maybe provided, and then the user can activate another channelwhich is electrically connected to either the anode or cathode asconfigurable through electronic switch circuits).

While hundreds of embodiments are realizable by the system usingpermutations of independent, ganged, or mixed circuits, the followingexamples will be illustrated using 2, 4, or 6 independent stimulationchannels. When stimulating a nerve that travels along a limb, using alimited number of defined channels provides easier adjustment of apreferred stimulation field by the user. Accordingly, the system mayonly use the channels defined in FIGS. 6a, 6b, and 6c (although theanode and cathodes may be switched so that cathodes are on the top ofthe matrix). Even if all 14 montages shown in FIGS. 6a-6n were includedin a candidate set of montages, this is still preferred over independentcontrol over each channel.

Because any combination of the 6 pads can serve as cathodes and anodesand further these can each utilize weighting values, a very large set ofpossible current steering settings are possible. To simply, in anembodiment, sets of predefined pairs of stimulation channels (e.g.,C1-A1, C2-A2, C3-A3) serve as a candidate set of stimulation montagesthat may be assessed and/or used during treatment.

The following examples shows that the triangle pad arrangement allowsfor fields that move from left to right, are oriented vertically orhorizontally or diagonally. While these are intended to be used withindependent channels, ganging or mixed montages (having both independentand ganged channels) are possible variations.

In an embodiment, both the center and left columns of the matrix are“activated” to provide stimulation signals that constitute a center-leftstimulation montage as shown in FIG. 6l , or the center and rightstimulation pad pairs are used to provide a center-right stimulationmontage as shown in FIG. 6m . Sequentially providing stimulationmontages selected from a series of stimulation montages shown in FIGS.6a, 6l, 6b,6m, and 6c allows users adjust the stimulation field locationacross 5 horizontally displaced zones defined from the leftmost torightmost side of the stimulation matrix. The user can then select azone from the group including: Left, Center-left, Center, Center-right,and Right.

FIGS. 6d and 6e show embodiments where the field crosses diagonallybetween the left and right side of the matrix. A narrower field mayincrease the chance that a nerve will be recruited, while using lesselectrodes than in embodiments such as in FIG. 6k . If the currentsupplied using 2 pads versus 4 pads is kept constant, then fewerchannels will increase the current density since less area is used toprovide stimulation when only 2 pads are used. FIGS. 6d and 6e can alsoprovide increased current density (anodic) compared to that shown FIGS.6f and 6g . A narrower diagonal field may also reduce risk of evokingcollateral muscle activation. In an embodiment, as shown in FIG. 6f , C1(cathode) and A1/A2 (both serving as anode) form a circuit that isslightly proximal on the leg to that of FIG. 6 l.

In an embodiment, if a subject indicates good recruitment but alsoindicates calf muscle activation, then an additional set of stimulationmontages may be provided that enables the user to adjust the fieldlocation in a new manner, such as allowing location adjustment to bemore proximal and away from the calf. For example, if a subject prefersstimulation from the center column (e.g., C2-A2), but reports calfmuscle activation, then instead of asking a user to move the entirestimulation matrix higher on the leg, the stimulation program canattempt to shift the field more proximal. For example, in an alternativeembodiment which is not shown in the figures, the leftmost (C1) orrightmost (C3) electrode can serve as cathode and all the pads on thetop half of the matrix (A1, A2, A3) serve as anode to form a circuitthat allows stimulation to occur slightly proximal to that which occurswhen C2 is used. This proximal shift in the location of the stimulationfield on the leg may allow stimulation to be provided withoutstimulating muscle such as calf muscle. Alternative stimulation montagessuch as 6 d, 6 h or 6 j can be attempted since these both involvestimulation of the center zone without involving the distally locatedstimulation pad of C2. Alternatively, both anode and cathode can beassigned to the top triangle as shown in FIG. 6n and further only thetop of the triangle is activated. Accordingly, in an embodiment, inaddition to montages which move the field along the left/right axis,there is a set of stimulation montages associated with a “shift up” or“shift down” option which will adjust a field to be more proximal ormore distal compared to the current stimulation montage.

Further, the montage shown in FIGS. 6i and 6j allow the field adjustmentdownward and upward to that shown in FIG. 6h . Accordingly, while thefield steering managers shown in FIGS. 5a to 5e illustrate controls formoving the left-right bias of the stimulation field, the stimulationmatrix using 3-pad triangular sets of as disclosed herein also permitsusers to adjust the field proximally and distally along the axis of thelimb when an Up/Down control is provided to allow users to toggle thatparameter.

In the embodiment shown in FIG. 6e , channels C1 and A3 form a diagonalcircuit that extends from the bottom left to the top right regions ofthe stimulation matrix. This stimulation montage may offer an advantageover a strictly vertical field (e.g., C1-A3) due to at least one of: a)shape/orientation of the field, especially in the cathodic region, mayhave a higher chance of intersecting a nerve travelling along the axisof a user's limb but is not directly under the cathode; and, b) theanode electrode may have a reduced hyperpolarizing effect on a differentarea of the modulated neve (to interfere with potentials travellingproximal or distal to the stimulation site). A diagonal montage mayoffer an advantage when attempting the record SNAPs above or below thestimulation electrodes.

In an embodiment, more than one stimulation montage may be selectedduring the provision of stimulation, or different channels of astimulation montage may provide different stimulation signals. Forexample, an “effective” stimulation frequency such as 20 Hz is suppliedby the combination of a first diagonal channel C1-A3 providing a 10 Hzpulse train signal, and a second diagonal channel C3-A1 providing asecond 10 Hz pulse train signal. The two signals are offset by half acycle and combine to produce a 20 Hz signal in the tissue that commonlyreceives stimulation from both channels. Without being limited bytheory, one advantage of this stimulation protocol is that a nervetarget is stimulated using two different stimulation vectors and one ofthese may be more optimally aligned to recruit the nerve. Also, lowercurrent density at each electrode location may minimize cutaneous nervestimulation. Additionally, both 10 and 20 Hz have been shown to producestrong therapeutic effects which stimulating the saphenous nerve inanimal bladder-fill models (see Yoo and John, U.S. Pat. No. 9,610,442).Accordingly, even if only 1 channel is successful in recruiting thenerve, benefit should still be obtained.

In an embodiment, the stimulation protocol may select a stimulationmontage from a set of 2 or more stimulation montages to be used atdifferent moments in time. This may be useful in decreasing the risk ofskin irritation compared to using a single circuit for the entiretherapy session. Additionally, if a user indicates that they “like” 2different stimulation montages, then switching between these duringtreatment stimulation may provide improvement if one of the montagesprovides better nerve modulation of the SAFN, although this is notperceived by the subject.

Turning now to FIGS. 6h to 6j , it should also be noted that thestimulation matrix permits not only vertical displacement (6 h is moreproximal), but FIG. 6h also creates a more vertically compact and broadstimulation field that may also be shallower than that provided by thatshown in FIG. 6b . In embodiments, stimulation montages which havedeeper field paths may be selected in response to a user who toggles acontrol for adjusting the stimulation field “deeper”.

Lastly, FIG. 6n shows an embodiment where both the top set and bottomset of stimulation pads of the top half and bottom halves of the matrix14 includes both anode and cathode assignments. A stimulation circuitcan be defined and established solely within the top or bottom set ofstimulation pads. While the resulting stimulation field may not extendas deep below the skin surface as occurs with larger inter-pad distance,it may be sufficient. This compact stimulation montage is more likelyfor target nerves in the arm or leg that are sufficiently shallow to theskin surface. Additionally, when stimulation signals are provided duringa post-treatment stimulation interval, and designed to prevent skinbruising by increasing blood flow to the region under the pads, a moreshallow stimulation field may offer advantages such as stimulationlocalized to the skin/pad interface area.

Rather than selected channels being active and others being deactivated,3 pairs of pads (C1-A1,C2-A2, and C3-A3) can all be active and form 3separate circuits, and the amplitude weights are set so that one of the3 pairs of pads has higher amplitude (“primary”) and the other channelshave lower amplitudes (“non-primary”). Human testing was carried out ona small group of 13 subjects and results indicated that almost allsubjects confirmed they could discern when the stimulation fieldtransitioned between the 5 zones when these were provided using 5 setsof amplitude weights values for the 3 columns of the matrix.Accordingly, as will be disclosed, rather than being active or inactive,in embodiments of the SaphLocate feature, all channels are on, but theselected channels are set with higher amplitude weights to bias thestimulation field maximum in a selected location.

Multimodal Field Adjustment.

Graphically presenting information about the stimulation field can aidusers to better distinguish between, or anticipate, differentstimulation field geometries. For example, a highlighted circle on theright or center-right side of the display can cause a user to focusattention on the skin below the right side of the matrix as indicated bythe display as shown in FIG. 3b . While useful for a small set of pads,such as 3 pairs of circuits that define 3 columns of a stimulationmatrix (e.g., A1-C2, A2-C2, A3-C3), more detailed displays can assistwhen more complicated stimulation montages are defined as possiblepermutations such as those shown in FIGS. 6a-6n . In embodiments, therelative weights or stimulation signal intensities of signals output ateach stimulation pad are visually represented using a heat map of thestimulation matrix and/or displaying numerical values at the location ofeach pad that correspond to the strength of stimulation. A color-codedmap can be generated by the user interface module 48 to show users theintensity provided at individual pads, or the calculated field intensityof vector fields integrated across the modeled stimulation fieldcalculated by the virtual module 50 a.

The perception of both stimulation and changes in stimulation can bereinforced by operating the user interface module 48 to provide signalsin the auditory and or visual modality with the user device 20 a or theneurostimulator 12. The SaphLevel and SaphLocate software programs areconfigured to provide reinforcement signals such as: a) modulated soundand/or light stimuli (e.g., a light modulated a, and synchronized with,the same frequency as stimulation), b) auditory or visual cues timed toa change in the stimulation montage (e.g., as each of 5 settings areselected these are accompanied by tonal cues; c) visual stimuli providedon the housing or a screen of the user device that show the region ofstimulation d) sensory cues with a volume or light intensity that areadjusted according to the amplitude/strength of the simulation signal.

Stimulation Montage Weighting Values.

In embodiments, a SaphLocate™ feature includes the use of appropriatelyselected stimulation channel weightings that permit adjustments instimulation field geometry to occur which meet a criterion. This may bethat changes in location are generally perceived or occur in a smoothmanner permitting subjective assessment and comparison of two or morestimulation montages. When comparing different candidate stimulationfield geometries, abrupt transitions of perceived intensity may be aproblem since these can interfere with a user's assessment of importantstimulation related characteristics such as judging presence of evokedparesthesia associated with nerve recruitment.

Characteristics that may be assessed by a user for determining astimulation montage can include one or more subjective sensations, suchas: subjective strength of the stimulation field; amount of unwantedmuscle stimulation; comfort of skin sensation under the stimulationpads; quality of stimulation under the stimulation pads (e.g., prickly,pulsing, sharp/dull, etc.); presence/absence of nerve recruitment;strength of nerve recruitment; area of paresthesia; quality ofstimulation induced paresthesia (e.g., vibration, tickling); overallcomfort during stimulation; absence/presence of pain or discomfort; orother therapy characteristic.

In an embodiment, an object of the invention is to cause a fieldprovided by a first stimulation protocol setting (e.g., using 2channels) to be perceived as approximately similar in strength to asecond setting (e.g., using 4 or more channels), while also allowing theuser to perceive a change in stimulation geometry or location, andenable a user to determine which geometry or location is preferred. Evenif the fields provided by a first stimulation or a second stimulationmontage provide similar target nerve recruitment capabilities, adifference in perceived stimulation comfort or tolerability maydetermine the preferred montage for use during subsequently providedtherapy.

Abrupt jumps (e.g., in perceived intensity) that occur when a useradjusts between different stimulation field settings hinder a user'sability to assess a change in a subjective measure due to a change inthe location (“zone”) of stimulation or a change in intensity. It is anobject of the invention that a 2-channel stimulation field will not beperceived as much less (or more) strong than a 4-channel stimulationfield simply because more stimulation pads provide the stimulationsignal and evoke more activation of skin receptors or cause jumps in thevector field. Large perceived jumps can interfere with a user's abilityto compare the difference of the two montages in recruiting the nerve.

An advantage of using weights to adjust signal characteristics (e.g.,amplitude) allow the geometry of the stimulation field to be adjustedacross different stimulation pad combinations without transient jumps inintensity, or other discontinuities, that would otherwise make itdifficult for the user to compare (or even prevent accurate comparison)between alternative stimulation patterns. While weighting values mayoften be applied to amplitude, these may also be adjusted for otherstimulation parameters such as pulse duration. The weighting values canalso be applied to the duration of the stimulation pulses of a channelso that the perceived intensity does not cause large changes betweendifferent stimulation montages. When the pulse width doubles, thecurrent density is the same but the charge delivered over time doubles,which may increase the strength or perception of the stimulation.

Another advantage is that when weighting values are used in thestimulation montages used during assessment of candidate montages,improved stimulation may be provided during the subsequent provision oftherapy. For example, use of weighting factors in channels that areadjacent to the primary channels (i.e. the channels with the largestintensity) may also enable optimized stimulation patterns to be found,that might not otherwise be found, since supplying energy in adjacentchannels may a) supplement the energy provided by the primary signal andprovides stronger nerve recruitment, b) supplement the energy providedby the primary signal in order to cause nerve recruitment to occurwhereas this would not have occurred if only using the primary channelsfor stimulation, c) enable recruitment to occur with energy in theprimary channel at a lower amplitude (due to vector field summation orother manner of increasing the ability of a stimulation signal of theprimary channels to modulate the nerve).

One SaphLocate feature that may be used to adjust stimulation channelweightings relates to a discovery by the inventors that when adjustingthe geometry of the stimulation field (e.g., when transitioning from aleftmost to a rightmost stimulation configuration), the perceivedstrength of the stimulation (or other subjective sensations) couldchange by a large amount or “jump”. Accordingly, SaphLocate uses alookup table with channel weightings that decrease these perceived jumpsbetween candidate stimulation settings to provide advantages such asenhancing a user's ability to select between different candidate fieldgeometries.

The subjective discontinuity between two stimulation montages can occurwhen a first stimulation circuit (e.g., a left pair of stimulation pads(C1-A1) is used in combination with second pair of stimulation pads(C2-A2) that forms a second stimulation circuit. When additionalstimulation channels are added, the perceived intensity of stimulationmay “jump” if the stimulation protocol uses a weighting strategydesigned to maintain an equivalent total current (integrated across allanodes or cathodes of the stimulation matrix). A problem here is that ifthe target nerve recruitment threshold is at 30 mA and the left circuitalone used 40 mA, and when the center circuit is added the channels areboth set at 20 mA, then suddenly the subject may not feel anyparesthesia. That is because the stimulation current at the nerve isbelow the target nerve recruitment threshold. Accordingly, the 4-channelembodiment should use a set of amplitude weight values for the channelsthat deters this type of unwanted result (e.g., use weighting strategiesthat maintains a stimulation current above a recruitment threshold).

In this example, adjusting the amplitudes of the 2 stimulation signalsmay compensate for the difference between the pad surface areasassociated with 2 circuits, to match the total current provided atsurface areas of the pads used by the 1 circuit of stimulation.Accordingly, the weighting value adjustment proportionately reduceschannel weighting value by 50% when the surface areas of the stimulationpads doubled.

In the table below, 100% (i.e., weight coefficient of 1.0) indicates astimulation signal (e.g., 20 mA) is provided without attenuation, whilea value of 50% (i.e., coefficient of 0.5) indicates the stimulationsignal current will be attenuated by 50% (e.g., 10 mA) for thatstimulation circuit. The weights can also be defined for individualchannels. In an embodiment, a set of weights is configured to maintaintotal current as shown in the table below having sample weightingfactors used when transitioning from 2 channel to 4 channel stimulationmontage. In contrast transitioning from a 100% weighting value for theleft channels to 100% at both left and center will maintain currentdensity over a larger area of tissue but will lead to a large increasein perceived stimulation strength. Both scenarios interfere with auser's comparison between the two stimulation montages.

The weighting values adjust intensity of the stimuli such that if a userincreases the strength parameter value of the stimulation signal (e.g.,from 30 mA to 70 mA, where a possible range is 0-100 mA) then this newstrength value will be used to set the amplitude of the signal providedat each stimulus channel of a circuit after the strength value ismultiplied by the channel's weighting coefficient, which in this exampleserves as a “gain adjustment factor”.

Location Setting Left- Right- Channels Left Center Center Center RightAll Left 100%  50% 0%  0% 0% 33% Center 0% 50% 100%  50% 0% 33% Right 0% 0% 0% 50% 100%  33%

In the above table, the amplitudes of the signals provided using 4channels (e.g., when a user selects Left-Center or Right-Center) areeach reduced to 50% (channel weighting=0.5) to maintain total currentdelivered by the stimulation matrix relative to the amplitude of thesignals provided by any of the 2 channel montages (e.g., Left, Center,Right). Similarly, for 6 channels, each circuit provides an amplitudeadjusted by a channel weight value of 33% (which is 33% of the amplitudeprovided when any one of the 3 circuits of channels are provided alone).Using 33% may be too low of a weighting value since, especially at loweramplitudes, this can cause the stimulation signal amplitude to dropbelow the sensation or recruitment threshold and/or because ofnon-linear slope of the perception—intensity curves. It does not permitcomparison between the “All” setting with the other montages in thetable. A weighting value of closer to 75% at each channel (and range of50% to 85%) may be more viable.

In addition, when adjusting between stimulation geometries, instead ofadjusting weighting values that correspond to amplitude gain, theaverage duration of the stimulation pulses may be adjusted to compensatefor increasing or decreasing the number of stimulation pads that provideone or more stimulation signals. For example, when increasing from 2 to4 stimulation channels a weighting factor can be applied to astimulation signal characteristic such as pulse duration, which can bedecreased to maintain a similar perceived signal strength. For example,the weighting factor can be adjusted proportionately or otherwise (e.g.,a duty cycle of 40% can be decreased to 20%).

As noted, the inventors have found that a strategy of dividing the totalcurrent (e.g., by the number of channels or stimulation pads) does not,in fact, yield desired results of increased smoothness. While the tableabove retains the same total current/charge delivered when movingbetween stimulation pad configurations, it appears to have thedisadvantage of causing large changes in perceived intensity betweenstimulation montages. This interferes with the ability of subjects tocompare between candidate montages and select a preferred montage thatprovides successful modulation of the SAFN (e.g., strongest or mostdistal sensation of paresthesia while minimizing collateralstimulation).

In studies performed by the inventors, it was determined that the changein field size due to current being supplied by different numbers ofstimulation pads (and changes in the integrated size and shape ofstimulated surface area and possibly strength of a vector field), or acorrection for that particular change that maintains total current, doesnot appear to be proportional to the changes in subjective strength ofthe stimulation signal. Maintaining a constant for total currentdelivered does not appear to correlate with a smooth perception ofintensity between different combinations of channels. In an embodiment,this strategy is avoided when setting weighting coefficients. Instead,these are selected to cause the change in perception of stimulusintensity for different stimulation geometries to be less than a“geometry change threshold maximum value” previously found as acceptablein a sample of subjects.

Without being limited by theory, several factors may contribute to whatis experienced by subjects when the field strength and/or geometry isadjusted. These may also explain why using weighting factors that areset to maintain the total current supplied by the matrix acrossstimulation montages that use different number of stimulation channelsis not a successful strategy. One factor may be the issue of cutaneoussensation thresholds. For example, if a subject's cutaneous sensationthreshold is 8 mA for a particular electrode set, and the amplitude of afirst stimulation circuit is 10 mA, then the stimulation field is abovethe threshold. If a second set of electrodes are added to thestimulation montage and the weighting factors are adjusted to maintainthe net total current (i.e., the signal is reduced to 5 mA per channel),then this will be below the sensation threshold and will not becutaneously perceived by the subject. Rather weighting factors can beadjusted in relation to skin sensation threshold, target nerverecruitment thresholds, perceived intensity, sensed neural activity orother consideration.

In an embodiment, in contrast to the correction factors that maintaintotal current delivered across stimulation pads, two characteristics ofstimulation weights are provided to decrease risk of jumps in subjectivesensations when transitioning between stimulation montages: a) weightsof adjacent channels to the primary stimulation channels are set toprovide lower amplitude signals rather than being set to zero, and b)non-primary channels, which are also non-adjacent (i.e., may beseparated from the primary stimulation circuit by at least oneintervening stimulation pad) are set to provide reduced amplitude (e.g.,current) stimulation rather than being set to zero. For example, in FIG.6a the primary stimulation circuit is A1-C1 (i.e., left sidedstimulation which provides the highest amplitude stimulation signals),and the non-primary stimulation channels are formed by adjacentanode-cathode pairs A2-C2 and A3-C3 of stimulation matrix 14.

In an embodiment, a Left stimulation field defines a primary stimulationcircuit (weight=100%) that is complemented by a lower amount ofnon-primary stimulation provided by non-primary stimulation channels.For example, weightings are as shown for the A1-C1 (100%), A2-C2(87.5%), and A3-C3 (75%) channels, respectively. In an alternativeembodiment the 3 weightings used for the “Left” stimulation montage are100%, 80%, and 67% which are revered for the “Right”. Alternatively, theweight values may be selected as: 100%, 70%, and 35%; or, 100%, 50% and20%. Accordingly, in embodiments, all 3 circuits are active in everymontage, and movement of the field is caused by changes in weights whichprovides maximum stimulation in different locations.

Stimulation Montage Selected by User Channel Left Left-Center CenterRight-Center Right Left 100.00% 93.75% 87.50% 81.25% 75.00% Center87.50% 93.75% 100.00% 93.75% 87.50% Right 75.00% 81.25% 87.50% 93.75%100.00%

Another benefit of using non-zero weighting values at stimulationchannels that are adjacent to the channels where the maximum stimulationfield is provided is that instead of a non-primary stimulation channelgoing from zero to some value such as 94%, increasing from 50% or 85% to70% is a smaller increase that allows for smoother transitions (andreduces the risk of the channel being below threshold prior to when itis increased).

In embodiments, if a user is surveyed and indicates that they do notfeel distinct changes in the location of the stimulation field, or ifthe changes are not perceived as occurring smoothly then the weights areadjusted accordingly (e.g., to make the changes more distinct theweightings of different channels would be separated by a larger amount).

Rather than using a look-up table, the weightings for the differentstimulation montages can be calculated using equations such as: Leftcircuit Amplitude=Amp*(BaseAmpW−(Location*SlideFalloff)(& Right PadAmplitude=Amp*(BaseAmpW−((4-Location)*SlideFalloff)); where “Amp” is theamplitude of the current parameter limited according to a range of theD/A buffer (e.g., 0 to 80 mA); “BaseAmpW” is the weighting valuepercentage for amplitude in the primary channels (e.g. left=100%),“Location” is assigned a value based upon the montage selected by theuser (e.g., 0, 1, 2, 3, 4), and “SlideFalloff” defines the slope valuefor attenuation at each non-primary channel (e.g., 6.25%). SlideFalloffcan obviously be adjusted to be steeper or non-linear (e.g., raising itto an exponent of 1.2)

In an embodiment, a set of stimulation montages are realized as 11left-right transverse zones with the weighting of the left circuit(C1-A1) set at each of the following values when the stimulation montage(“zone”) was set by a user as the following:

Far Mid Center Left of Right of Center Mid Far Left Left Left LeftCenter Center Center Right Right Right Right 100% 90% 80% 70% 60% 50%40% 30% 20% 10% 10%

When the “Far Left” montage is selected the amplitude of the leftcircuit of the matrix is attenuated the least and provides the maximumoutput according to the above equation. Alternatively, none of theweights may fall below a value such as 40% so that the left circuitstimulation remains on.

When a user assesses different montages to determine which may offerimproved recruitment, then large changes in stimulation “strength” mayinterfere with comparing alternative candidate stimulation montages.However, the difference between adjacent montages must also benoticeable. In an embodiment, a set of weighting factors for a set ofstimulation montages (e.g., 5, 7, 9, 11) is selected that both enables auser to distinguish between different montages (i.e., enable thetransition between alternative stimulation paths to be subjectivelyperceived as movement of a field), while also being devoid of unwantedchanges such as large changes in perceived stimulation intensityassociated with changes in field geometry. Weighting values may also beused to avoid these subjective jumps in sensation for other change instimulation montage such as anode-cathode designation, pulse width, etc.

In embodiments, adjusting the adjacent non-primary stimulation channelsby multiplying the output current by weighting values in the range of,for example, 75-90%, rather than zero, (and non-adjacent non-primarychannels in the range of 50-75%) enables the strength of adjacentstimulation montages to remain in an intensity range that cause subjectsreport changes in field geometry as “smooth transitions”. This strategyhas also been found to provide smooth transitions between montages whenthe stimulation matrix is applied to either the leg or the arm of users.

Factors Affecting Perceived Intensity.

Changes between perceived levels of stimulation strength may not changelinearly with intensity. Excessive jumps of perceived strength (i.e.,much higher than the just noticeable difference for change in intensity)may be due to non-linear strength/intensity recruitment properties ofcells under individual stimulation channel. A selected stimulationintensity which exceeds certain thresholds can be experienced as medium,strong, or very strong. Another factor is vector stimulation fromadjacent stimulation pads, which can cause the perceived intensity to beinfluenced by concurrent stimulation at the other pad. Regardless of theunderlying cause(s) of abrupt changes user's perception of intensity,these unwanted transitions should preferably be avoided. In embodiments,features of the invention permit unwanted perceptual jumps due to thesefactors to be decreased. An aim is the provision of smoother perceptionof transitions between different field geometries to enable advantagessuch as, for example, allowing different stimulation montages to be moreeasily compared by a user.

SaphLevel Embodiments.

In addition to benefits obtained when comparing different stimulationfield geometries, incorporating a weighted stimulation field duringtreatment stimulation can also provide advantages. In embodiments,SaphLevel uses montages of selected non-zero weights on selectednon-primary channels to provide increased comfort, increased nerverecruitment, preferred stimulation sensation, etc.

The inventors have found that some users prefer having at least onenon-primary stimulation channel concurrently stimulate at a lowerintensity that that provided by the primary stimulation circuit. Forexample, when a first stimulation circuit (e.g., C1-A1) providesstimulation the two non-primary stimulation circuits (e.g., C2-A2 andC3-A3), provide lower stimulation instead being inactive. As wasdisclosed earlier, an advantage was found in some subjects who reportedthe stimulation felt “richer”, “deeper”, or otherwise “morecomfortable”. Another advantage of providing lower weighted stimulationat adjacent stimulation pads is to cause nerve recruitment to occur witha lower maximum stimulation amplitude required at the primary circuit:accordingly, the stimulation signal of the primary channel is lesslikely to be near or above the pain threshold. Without being limited bytheory, this advantage can occur due to vector summation of thestimulation fields at the location of the nerve or due to recruitment ofa larger number of branches of a target nerve such as the SAFN.

In embodiments, the weighting values for the non-primary channels areset to change as the intensity of the signal of the primary stimulationchannel (with weight of 100%) is increased. For example, while a“center” montage may use weights of 80%, 100%, 80% for a first intensityrange, the weights change to 60%, 100%, 60% (typically for a higherrange). This feature is achieved by setting channel weights based on alookup table with row weights corresponding to defined intensity rangesand channels being defined in each column, or by a simple algorithmusing a set of “if/then” rules.

In embodiments, after preferred stimulation field settings are selectedusing SaphLocate features, the SaphLevel features are used to providetreatment stimulation with a montage that is different than the montageselected by the user using SaphLocate features.

Although many SaphLevel settings will use non-primary channelstimulation, stimulation may be provided only from the primarystimulation channels (e.g., non-primary channel weights are set tozero). This can provide a more focused stimulation field and decreasedrisk of stimulation triggering unwanted muscle activation or spasm.Alternatively, the SaphLevel algorithm may only set the non-primary ornon-adjacent channels to zero contingently. For example, the systemoperates the user interface module 48 to query a user about calf-musclestimulation. If the user indicates muscle activation is present,SaphLevel will decrease the weight values of non-primary channels or atleast of the channels closest to the calf muscle. In an embodiment, theSaphLevel algorithm uses information about whether the stimulationmatrix is applied to the left or right leg (e.g., input by a user) toassign lower weighting values of non-primary stimulation channels thatare located near the calf muscle compared to non-primary stimulationchannels on the opposite side of the matrix. When the stimulation matrixis applied to the left leg the right side of the stimulation matrix iscloser to the calf muscle, while on the right leg, the pads on the leftside of the matrix are closer.

In an embodiment, a SaphLevel feature sets channel weights ofnon-primary channel pads adjacent to the primary stimulation channels tolower values than the primary-channels. This stimulation protocol mayreduce some users reported discomfort or pain, and may enable a higherintensity level to be tolerated by a user. If a higher stimulationamplitude can be provided by the primary stimulation channels andtolerated by subjects (possibly due to phenomena such as sensory gatingand lateral inhibition), then this increased stimulation signal strengthmay a) increase the modulation of the target nerve, b) increase thechance for successful target nerve modulation, c) increase the strengthof the signal that is relayed centrally from one or more branches of theSAFN d) increase phase coherence of the average evoked neural response.Using an increased stimulation amplitude may increase the size of theevoked signal that is provided to the brain, providing a factor that cancontribute to increased “electrical dose”, and this may allow a decreasein total stimulation time, lower rate of users who do not achievetreatment success, or an increase in the corresponding therapy benefitor patient compliance.

Perception of the stimulation signal may be influenced by concurrentstimulation (with the same or different intensity levels) provided atmultiple locations. Not to be limited by theory, increased perceptual“richness” from a larger stimulation field that is adjusted according toselected weighting coefficients may be caused by several factorsincluding stimulation of additional nerve fibers, gate control, andlateral inhibition. These may influence a user's sensory perceptionincluding modulating pain sensation and paresthesia. Real world examplesof these physiological phenomena include applying pressure, rubbing, orscratching an arm region near a region where a user is experiencing painto reduce the sensation (e.g., itching a mosquito bite). Gate controland lateral inhibition models provides a basis for explaining hownon-painful stimuli can provide sensory input that interferes with(and/or functionally reduces) painful sensations. Painful, nociceptivestimuli will stimulate primary afferent fibers which send signals to thebrain via transmission cells. Increased transmission cellular activitycorresponds to increased perceived pain. Conversely, decreasedtransmission cell activity reduces subjectively perceived pain. Gatecontrol theory suggests a closed “gate” occurs when input totransmission cells, that relay signals to the brain, is blocked or“gated”, this reduces the resulting sensation level of pain. This mayprovide a physiological basis for observed effects of pain perception,reconciles the specificity theories and pattern theories, andincorporates interactions between small (unmyelinated) and thick(myelinated) fibers.

In the gate control model, the non-nociceptive fast (myelinated) fiberscan block the nociceptive slow (unmyelinated) fibers: “fast blocksslow”. The theory asserts that activation of nerves which do nottransmit pain signals, called non-nociceptive fibers, can interfere withsignals from pain fibers, thereby inhibiting pain. It is proposed thatwhen both small-diameter (pain-transmitting) and large-diameter (touch-,pressure-, and vibration-transmitting) afferent nerve fibers transmitinformation to the brain, less pain is felt (via reduced transmissioncell activity in the spinal column) when neurotransmission activity inlarge-diameter fibers overrides the ascending transmission of signalsfrom small-diameter (pain-transmitting) fibers. Accordingly, adding aslittle as 10% or even up to 100% of the stimulation provided on primarystimulation channels, using weights at non-primary channels, mayinfluence the overall sensation of stimulation and may decrease painthat would otherwise be felt by a user for a selected stimulationamplitude.

In an embodiment, the primary stimulation channels (e.g., central padsc2-a2) serve to provide the largest source of modulation of a targetnerve, while the stimulation provided at selected non-primary oradjacent stimulation pads supply an adjunct signal that: a) interfereswith; b) distracts from; c) competes with; or, d) otherwise modifies theprocessing of sensory signals that result in the user perception of thetreatment stimulation provided by the primary channels. Additionally,the adjunct signal can enhance or otherwise change the perception of theprimary stimulation signal.

In embodiments, an “adjunct signal” is designed to serve as a “sensorymask” that masks the sensations produced by the signals supplied by theprimary stimulation channels. This specification has typically discloseda signal provided at non-primary stimulation channels as the same signalthat is provided as a stimulation signal, albeit at lower intensities.In an alternative embodiment, non-primary stimulation pads provide anadjunct signal that is different than the stimulation signal providedfor the purpose of target nerve modulation. For example, the adjunctsignal may have different frequency or waveform characteristics than thetreatment stimulation signal. Adjunct signals may be designed to alterthe user perception of the treatment stimulation signal. Mask signalsmay be a low intensity, high frequency, carrier signal or may beprovided with pads arranged to primarily stimulate the superficiallayers of the skin to simply produce competing sensory input. Inembodiments, the sensory mask is provided by non-electrical modalitiessuch as, vibration, sound, pressure, magnetic energy, or heat/cold. Thesensory mask may be constant or modulated at a selected rate.

In an alternative embodiment, two or more signals are applied fromchannels of the stimulation matrix and are designed so that theircombination (vector summation) at the target nerve produces the desiredstimulation waveform while the sensory experience of the stimulationwaveform is improved compared to that which would occur using the samestimulation waveform itself at all channels. In other words, adjustingthe stimulation montage of the stimulation matrix by activatingdifferent arrangements of active channels, or the signals provided bythose channels, to control field steering may incorporate principles andstrategies related to stimulation signal summation (and may be intendedto produce beat or other frequencies at a target).

Considerations and Advantages of Selected Stimulation Matrix Designs.

An alternative to a stimulation matrix with triangular pad arrangementsis a four-pad “plus” arrangement shown in top half of FIG. 7A. A furtherembodiment uses two sets of 4 pad arrangement for a total of eight pads.The plus arrangements provide a benefit of long or short channelseparations (e.g., C4-A4 and C2-A2) and larger range of verticallydisplaced/oriented fields, while using only 2 additional stimulationchannels. A matrix with preferably 4 to 10, and more preferably 6 to 8,and most preferably 6 stimulation pads arranged in a fixed manner canallow robust stimulate of the SAFN.

SaphLocate Methods with Sensory Criteria.

Providing stimulation with a limited set of stimulation montages cangreatly increase the ability of users to obtain robust stimulation of atarget nerve. Only single-axis adjustment may be needed when the matrixis used to stimulate a nerve that travels along the limb of a user.Limiting the number of selectable stimulation montages to a set whichincludes 5-10 montages makes the adjustment of the stimulation protocolmanageable. Defining a series of stimulation montages that adjust thelocation along a single axis such as the left-right access of thestimulation pad further simplifies selection of stimulation protocol bythe user. Weighting of the channels of the matrix can allow differentstimulation montages to be selected while meeting criteria such assensory criteria which includes providing a series of adjustments thatoccur without perceptual jumps in stimulation intensity.

FIG. 8A shows a method for providing stimulation protocol assessmentprior to, or during, stimulation treatment. In step 100 one or morestimulation signals for a set of N channels are created or selected.When stimulating the SAFN for treatment of OAB, a 20 Hz stimulationsignal with biphasic square waves may be the default signal provided atall channels. Step 102 includes establishing a limited set ofstimulation montages (i.e., channel assignments, weights, etc.) that canbe selected or assessed by a user. The weights of the stimulationmontages are adjusted to enable a sensory criterion to be met such asenabling the perceived intensity of stimulation to be approximatelysimilar when the user adjusts the location of the stimulation fieldusing the stimulation field adjustment controls. The set of stimulationmontages are selected to provide an orderly transition for acharacteristic of the stimulation field, such as changing the region ofmaximum stimulation amplitude along at least one axis of the stimulationmatrix such as from the left side to the right side of the matrix, orfrom the bottom to top of the matrix. Step 104 includes establishing amontage series which includes a set of montages presented in a definedorder. Step 106 includes providing stimulation and using the stimulationcontrols to obtain user input and responsively adjusting montagesaccording to adjustment rules. For example, if a user selects the leftor right control of a directional control then the montage is adjustedby incrementing or decrementing the montage according to a definedseries that provides movement of the location of the field from the leftto the right side of the stimulation matrix. The stimulation controlsmay also be defined to adjust characteristics of the stimulation fieldincluding the spread or fall-off of the stimulation field in pre-definedmanners. In embodiments, a defined shape of the stimulation field isadjusted to move across a stimulation matrix in a left to right or upand down direction. In step 108 user data is obtained such as a userindicating preference for one or more stimulation montages or obtainingsensed data which is assessed to determine if nerve recruitment hasoccurred. In step 110 treatment stimulation is provided to a user basedupon one or more stimulation montages selected by a user. In anembodiment, the stimulation montage selected by a user is used toprovide treatment stimulation. Alternatively, the weights of a selectedmontage are adjusted (e.g., weights of non-primary channels are reduced)and then stimulation is provided to the user during therapy. If morethan one stimulation montage has been selected by a user during theassessment procedure than the treatment stimulation may alternatebetween two or more stimulation montages during the provision oftreatment according to parameters of the stimulation protocol (e.g., thetreatment stimulation alternates in 5-minute intervals between twostimulation montages).

Guarded Stimulation Configurations.

In embodiments, the stimulation pads can be configured with an anode setto flank a cathode channel laterally, longitudinally, or both tosurround and “guard” the cathodic field. This may allow a strongersignal to be used at a cathode while controlling spread of the field ina direction where an anode is placed. An example of anode guarding isshown in FIG. 7B, where cathode C4 is flanked by anodes A1, A3, A4 orFIG. 7c where a cathode is guarded by a set of anodes (A1, A3, A4, andA5). In this manner the longitudinal (along the vertical axis/length ofstimulation pad) or transverse (along the horizontal axis/width ofstimulation pad) stimulation can be “guarded” in an adjustable orselective manner to decrease risk of calf or other muscle activation.“Guarding” a cathode can also result in driving the current deeper intotissue. Guarding can improve recruitment of the target nerve byconstraining the stimulation field, driving it further below the surfaceof the skin, and selectively avoiding unwanted stimulation of nearbytissue such as a calf muscle (e.g., soleus and gastrocnemius muscles),or biceps brachii, brachioradialis and coracobrachialis muscles when atarget nerve is in the arm.

Field Steering: Shaping, Offsetting, and Depth Adjustment.

In embodiments, field steering controls of the system 10 a provide forthe adjusting of: geometry of the provided stimulation (e.g., thepattern of active channels); the location of a geometry (e.g., selectingdifferent subsets of channels to change the location of a stimulationpattern in a proximal-distal, medial-lateral, or anteroposteriordirection); the shape of the stimulation field below the skin surface;and, the depth of the field (e.g., using such features asanode-guarding, high-frequency carrier waveforms, longer durationpulses, or adjusting the distance between activated stimulation padssince further distances can provide a deeper field). In embodiments, thesystem's user interface module 48 allows a user to independently adjustfield shaping with user controls related to adjusting stimulation fieldgeometry, offset, depth, and guarding parameters. For example, useradjustment of a field characteristic is done by making pre-specifiedadjustments to a stimulation montage or selecting a series ofstimulation montages which are organized to provide desired adjustment.When used for stimulation of the saphenous or posterior tibial nerve,adjusting the field's “depth” and driving the field deeper may provideimproved nerve targeting while avoiding unwanted modulation ofcollateral tissue.

The App 21 has screens that provide virtual controls includingduplicates of stimulation controls provided on the housing or display ofthe device 12, such as controls for amplitude and stimulation location(e.g., “+/−” virtual controls of FIG. 10c and FIG. 10d ) or treatment(FIG. 9d ). The app 21 may have additional screens with controls foradjusting the stimulation field as well (e.g., FIG. 5g ).

In an embodiment, a first set of stimulation controls can modulatestimulation parameters related to geometry and location of the field toprimarily allow for shaping and movement of the field across differentareas of skin under the stimulation matrix. A second set of stimulationcontrols permits adjustment of field “depth” (e.g., using parametersrelated to anode guarding, pulse duration, carrier frequency, orselecting circuits with small or large inter-pad spacing). A graphicaldisplay may show the shape of a modelled stimulation field including acalculated location for the maximum amplitude of the stimulation fieldin relation to the remaining field. Visualization of the calculateddepth of the field may rely upon numbers, color displays or 3D graphs.If a user modulates a “depth” control a graphical depth indicator ornumerical display will reflect the adjustment to the stimulation field.This is accompanied by a change in the stimulation montage (e.g.,stimulation pads located further apart are activated to provide a deeperpath of stimulation such as using C2-A2 rather than C-A4 of FIG. 7B).Alternatively, the depth and geometry of the field may be represented ona 3D grid that can be rotated by the user, or by using both a shapedisplay and a depth display, or by other display embodiments that allowa user to view and/or adjust (via touch screen) the shape, location, andmodeled depth of the stimulation field relative to the skin surface.

In an embodiment, a user interface allows field steering using arepresentation of the stimulation field on a touch sensitive screen of asmartphone user device 20 a. As shown in FIG. 5i , a graphical shapesuch as a dot, circle, or geometric shape is presented at locationcorresponding to a field maximum or a field's geometric center. Theshape or maximum is adjusted by a user “dragging” an area of the imagewith a finger. The user provides a gesture to adjust the central pointof the stimulation field (centroid) which can be superimposed on adisplay with a background image such as an anatomical representation ofthe leg or image of a stimulation matrix. The virtual fieldrepresentation is superimposed on the image with a correspondingposition and distribution. Further, a user gesture such as pinching theshape of the field shown on the screen (e.g., between a thumb andforefinger to “squeeze” the shape of the stimulation field), serves tonarrow the field, or adjust its depth (e.g., using anode guarding),according to an adjustment algorithm that is programmed into the userinterface module 48 and corresponds to the indicated adjustment.Alternatively, the user interface module 48 may present a display thatincludes a “shield” icon. Establishing or moving the shield on thescreen will bias the field away from a shielded location to restrain astimulation field from an unwanted area (e.g., by adjusting thecorresponding anode guarding characteristic of the stimulation montage).

In an embodiment, field steering or other stimulation characteristic aredetermined based upon physical attributes of a user that may be obtainedas part of patient onboarding due to surveying of a user (see step 108of FIG. 8b ) or medical data that may otherwise be available for a user.For example, characteristics of a stimulation regimen (locations, fieldsteering parameter values, or waveforms) or ranges of parameters values,are adjusted based upon physical attributes such as body mass index(BMI), calf circumference, presence/absence of edema and measurements ofedema severity, information from imaging data such as nerve location,subdermal fat/tissue characteristics, or measured tissue impedance.Physical attributes are input to a model or algorithm that selects oradjusts the stimulation regimen to improve nerve recruitment. Forexample, patients with edema or higher BMI may obtain greater nerverecruitment from a regimen that drives the field deeper into the tissueaway from the skin surface (e.g., by anode guarding or stimulationwaveforms that incorporate high frequency energy for improvedtransmission or other benefit).

The system 10 a can use predictive analytics, A1, ranking algorithms,and machine learning to analyze and adjust treatment according to dataof one or more subjects. These types of analysis can be used to predicttreatment outcome based upon user data, to determine users who shouldsee a urologist due to lack of symptom improvement, to determine userswho can provide treatment at home independently, or who should be guidedby remote medical assistance (i.e., increased level of interaction) todeter non-compliance or quitting. Changes in user data over time mayserve as cues that require intervention. For example, it may be foundthat if a user rating of satisfaction with therapy is below a value(e.g., 7 on a 1-10 scale) that referring the user for a telemedicinesession will decrease risk of them stopping the therapy.

The system may use artificial intelligence, machine learning, or otherrule-based algorithm to correlate the success of various stimulationparameter settings to outcomes across a population of users. Based uponsensed data, measurements made by a user, or answers provided to surveytimes, the system may then recommend certain stimulation montages, orother system characteristics, that are more likely to work best forindividual users. In an embodiment that serves as a simple example, thesystem may first query a user about presence/severity of edema, and alsothe type “pitting” or “non-pitting”. If a patient indicates they havepitting edema, the system may suggest the use of a light pressure on thestimulation pads while for non-pitting edema high frequency energy orinterferential-stimulation strategies may be suggested or used toincrease the depth of transmission of energy through tissue.

Additionally, waveforms may be selected that provide sensationspreferred by a user (e.g., a lower sensation of stimulation or pain atthe stimulation sites). If a user has high sensitivity to cutaneousstimulation at stimulation sites, then a higher frequency energy, orother waveform characteristic, may be selected to improve user comfort.Alternatively, a matrix with larger stimulation pads may be selected toincrease comfort and decrease current density within the cutaneous areanear the pads. Additionally, if a user does not like the feel of thestimulation induced paresthesia, a different waveform may be used thatdecreases or changes the paresthesia sensation, or a mask stimulus isprovided.

Impedance Measurement

A current-controlled system would typically mitigate most issues relatedto differences in impedance. Although current controlled stimulationcompensates for impedance of individual channels, if the differencebetween channels is too large, or if one or more channels of thestimulation matrix has poor impedance then problems can arise includingproviding improper stimulation. Impedance monitoring may also play animportant role when using ganged stimulation or constant voltagestimulation protocols. The EM module 46 monitors impedance sensed by thesensing module 44 and manages device operations if impedancemeasurements fail impedance criteria by operating according to “improperimpedance” rules. Defined operations can include, for example, setting aflag in the control module 40 to cause it to pause stimulation and/orprovide a user alert (by controlling the stimulation module 42 and/oruser interface module 48).

In an embodiment, the EM module 46 is configured with impedanceassessment circuitry and software routines configured to permitstimulation and/or field steering to occur correctly using thestimulation matrix. For constant current stimulation it may adjust thecompliance voltage of the stimulation provided at higher impedancestimulation pads within tolerable range based upon changes of impedancethat occur during therapy. However, if the difference in impedance forone or more pads relative to other pads exceeds a threshold value, thenthe actual stimulation field may deviate from the intended field and thedevice's stimulation circuitry will not be able to compensate. Even whenusing 2 stimulation pads it may be difficult to determine which one ofthe two pads is suffering from poor impedance. In embodiments, to detectan impedance problem, the EM module 46 is configured to test sets ofstimulation pads according to a sequence defined in a lookup table. Forexample, for a set of three active pads, the circuitry can sequentiallytest defined pair combinations such as: pad 1 against pad 3; pad 2against pad 3; and, pad 1 against pad 2. If the circuit created by pads1 and 3 has acceptable impedance, then pad 2 is indicated to have aproblem. Impedance may also be evaluated for pad combinations includingmore than 2 pads: pad 1 is assessed against a set of 2 or more padswhich in this example are pads 2 and 3. When 6 stimulation pads are usedthen the average impedance of 5 pads can be compared to the impedance ofa sixth pad using a criteria which sets a limit for the difference basedupon value such as 1-10 kOhm, or based upon a percentage such as +150%(i.e., the difference between any tested channel of a set stimulationpads can exceed 1-10 kOhm or be over 150% of the impedance measured atother circuits). In an embodiment, when 6 pads are used then the testscan be based upon sequential combinations of 2 pads (e.g., 2 of the 3pads of the upper or lower triangle or each of 3 defined verticalcircuits for the left, center, and right circuits). In the assessmentmethod, a circuit of at least 2 pads must fail an impedance test beforean action (e.g., alerting a user, assessing and using an alternate“substitute” stimulation pad, etc.) occurs. Based on this assessment, ifany impedance test conducted by the EM module 46 fails a definedimpedance criterion, then the system will provide an operation definedin the EM module 46 such as: a) operating the user interface 48 moduleto provide an indication of the problem to a user, b) selecting andactivating an alternative stimulation pad or c) setting the pad to aninactive state. For example, an alert such as a flashing light (ortoggling a diode color from green to red), a vibration, or tone may beprovided to a user by one or more transducers of the EM module 46 usingthe neurostimulator 12 or user device 20. Additionally, a text messageor graphical depiction of the matrix on a user's leg is presented withcolor coded impedance values that indicate to a user the status ofdifferent pads 16 of the matrix 14. The text message (or pushnotification) can inform a user of high impedance for a region of thematrix (e.g., the upper right corner) or can instruct a user to “checkpad contact on the top right of the matrix”. Impedance assessment canoccur at the start of a therapy session prior to provision of therapy,during the provision of therapy, and/or periodically (e.g., every 5minutes). Impedance measurement can include pausing stimulation therapyshort periods (e.g., 50-500 msec) or for up to several minutes duringnon-stimulation “rest” periods are defined as part of the stimulationprotocol. Impedance measurement may also occur in a statistical mannerthat averages a number of measurements over a selected interval, or mayrequire impedance measurements exceed a selected level for a minimumduration before it is assessed to be “unacceptable”. If the impedance isnot acceptable it may provide an auditory alert periodically, which canincrease in volume over time, so that this is not ignored by the user.The control module may pause therapy if impedance measurements are notreduced after a selected number of alert signals (e.g., beeps) arepresented to a user. Additionally, if impedance exceeds a selected levelthen stimulation can stop automatically.

In an embodiment, when a single cathode “C1” is used with three gangedanodes (A2, A3, and A4) then the system first determines if any channelsuffers from improper impedance by sequentially testing the C1 againsteach anode prior to providing ganged stimulation.

Impedance matching may be useful with ganged embodiments. For example, afirst ganged embodiment is realized by electrically combining the top 3stimulator pads and, separately, the bottom 3 stimulator pads, such thatall three top electrodes serve as Cathode and all three bottom serve asan anode to form a single stimulation circuit. The current will not flowequally between the 3 stimulator pads of each set, but rather will be afunction of at least: a) skin and deeper tissue impedance along thepathway between electrodes; and, b) arrangement of pads/interelectrodespacing. The amount of current that passes between two stimulation padscan be modulated (i.e., decreased) by the stimulation subsystemcircuitry which can introduce additional resistance between a particularstimulation pad and a channel of one or more of the stimulus generators(e.g., in a voltage-controlled system). Other methods of impedancematching for ganged stimulation designs may also be used.

In an embodiment, a voltage controlled ganged stimulation protocol suchas a single pad in the bottom half of the matrix (e.g., C2) that isreferenced to two stimulation pads in the upper half of the matrix (A1and A3), may have unequal current flow to the upper pads. Impedance canbe measured between the two circuits (e.g., (C2-A1 and C2-A3)) tocompensate. In an embodiment, a set of resistors varying across aselected range are dynamically included in the circuit to enableapproximately similar current flow along the two paths to increase theuniformity of the field bank.

In some voltage-controlled embodiments, the system senses impedanceacross circuits defined for different combination of stimulation pads.The impedance measurements are used to create a modeled fieldrepresented by the heat map display. For example, higher impedance maycause less current to flow between 2 or more of a set of stimulationpads and the current flow is modeled as stronger across adjacentchannels having lower impedance. The modelled stimulation field caninclude model parameter values related to: signal amplitude, electrodeshape, size, and arrangement (inter-pad distance, and orientation) ofthe pads in the matrix (i.e., “matrix pad geometry”). Modelling can alsoincorporate sensed impedance as measured between different pairs ofstimulation pads to set values of tissue resistance or impedance of theskin-hydrogel interface.

Adjustment of Stimulation Signals and Montage Characteristics and UserSurveying.

Various factors, such as pandemics, can make telemedicine preferable toin-person doctor visits. The system 10 a is designed to allow set-up tobe accomplished by a patient working independently or under the guidanceof a medical professional. In both cases, the digital ecosystem module50 manages user training about the stimulation 104 during onboarding.When a user adjusts and selects preferred stimulation field settingssuch as geometry, location, and intensity, the system obtains user inputresponses about stimulation evoked sensations.

In an embodiment, during training or therapy the system surveys a userto describe sensations associated with nerve recruitment by presentingchoices such as: “Tingling, vibration, tickling, thumping, pinching,biting, other”. Survey items may also relate to perceived intensity orcomfort, with choices such as: “light, medium, strong, uncomfortable,painful, intolerable”. Scale attributes can be combined such as “lighttingling”, “medium tingling”, “strong tingling” etc. Further, thedefined training protocol can contingently prompt a user 106 to increasestimulation intensity if user input indicates the sensation isinsufficient, e.g., only a “light tingling”. Training program maycontingently 106 display a message for a user to use an alternatesetting such as “A medium or strong tingling that radiates up or downyour leg may work better, would you like to try increasing theintensity?” If the user approves a proposed option then the user isprovided with a user display having controls that enable the option tooccur i.e., adjustment of at least intensity. If the user rejects theoption, the program may simply move to the next step of completing thetraining. If the system is designed to provide stimulation of a nervetarget in a human arm, then software settings and labels are adjusted tobe appropriate for the arm instead of a leg. For example, when surveyinga user about paresthesia the survey item is anatomically appropriate:“extends to the tips of their fingers” is used rather than “to theirtoes”. Similarly, surveying about paresthesia “moving towards the knee”is replaced with a “moving towards the shoulder” option.

The SaphLevel or SaphLocate features incorporated into training ortherapy provision may survey about the location of the paresthesiaassociated with a selected intensity or stimulation field geometry.Choices may include, for example: “directly beneath the stimulationpads”, “above the pads towards the knee”, “below the pads toward theankle”, “down to the ankle”, “into the foot”, “all the way to the toes”.Alternatively, a map of a body part such as a leg (or lower leg, fromthe knee to foot) is displayed and the user is instructed to tap thegraphical display to indicate one or more regions related to paresthesia(e.g., the lowest point where paresthesia is felt). An “x” may then beplotted at the spot (See FIG. 9e ) and the user asked to confirm. If auser indicates that the stimulation is only felt “directly beneath thepads” then the system can contingently prompt a user to further adjustan intensity or montage characteristic such as to produce a paresthesiathat spread away from the location under the pads.

In embodiments, during training 104 the user is specifically queriedabout the presence of calf, or other muscle, stimulation. The surveyingmay ask about the presence of foot movement or cramping. If a userconfirms this unwanted side-effect during onboarding or therapy adefined number of times, then the system may contingently operate 106 toschedule, or prompt a user to schedule, a virtual meeting with a medicalprofessional. Alternative contingent operation 106 includes setting aflag value on this parameter in a log record or patient profile.Alternatively, the system may contingently operate 106 to instruct auser to select a different montage or present users with an “advanced”screen of controls (e.g., FIG. 5j ) that guides, or otherwise allowsusers, to utilize a more detailed set of field steering controls thatpermits anode guarding or field shaping controls that assist a user toadjust a field shape, location, or orientation away from an unwantedlocation to avoid the unwanted side effect. In addition to permitting orguiding a user to decrease muscle stimulation using these adjustments,the system can also allow adjustment of the stimulation signal. Forexample, a default pulse train stimulation waveform is replaced with analternative such as burst stimulation, or interferometry stimulationsignals, or a high frequency carrier (e.g., 500 Hz-100 kHz) which isunmodulated or modulated by an envelope with a nominal frequency (e.g.,1-100 Hz) and pulse width (e.g., 10 us-1 msec).

Curated Neurostimulation Programs: Onboarding.

In embodiments, the onboarding process guides users through the firstuse of the system 10 a. Shorter onboarding sequences can also be definedto occur at the beginning of each therapy session. The NiNA ecosystemprovides a curated user onboarding process that includes features suchas providing an overview of the therapy, training the users on providingstimulation, surveying users to develop a user profile and set userpreferences, and providing educational content. Users are providedinstructions on series of topics, are asked to perform operations andactivities, and may be surveyed, with user responses logged. Onboardingmay include instructing (or asking) a user about which leg they will useduring the treatment session; instructing users to adjust acharacteristic of stimulation, location, and intensity and survey theuser about perceived sensations (for at least one intensity or montageselected from candidates); asking a user to indicate information usingimages; prompting a user to provide or confirm information by obtainingimage data, such as taking a photograph of the device on their leg totrack device placement, etc. This process can occur primarily usinginformation presented visually with user interaction of a smartphone 20a or can incorporate interaction with a virtual assistant technologysuch as an Amazon Echo device 20 e that provides instructions andobtains, processes, and stores a user's speech-based responses.Onboarding operations may also be complemented by image data obtainedusing an image capture device (of a phone or webcam) which provides datato a software engine that can identify user behaviors through imageanalysis to automatically identify user activity such as determining theleg for which the wearable has been attached (and the position of thedevice on the leg), etc. The information obtained by visual and auditoryinteraction with one or more system devices can then be logged anduploaded to a remote computer 20 f or to the user device App 21.Onboarding can use screens such as those shown in FIGS. 10a -10 k.

FIG. 10a shows a screen 258 for providing features that educate a userand provide an overview of the therapy process.

FIG. 10b shows a screen 260 for providing features that train the user104 on correctly securing the wrap to the leg and adjustingcharacteristics which may be related to location and pressure.

FIG. 10c shows a screen 262 for providing features related to trainingof the user 104 on how to adjust the stimulation intensity and FIG. 10eshows a screen for providing features related to training a user on howto adjust the location of the stimulation field. Either of these stepscan include or be followed by surveying the user about the quality,intensity and location of sensations including paresthesia such as seenin screens 264 and 266 depicted in FIG. 10d and FIG. 10e . Users may beasked to provide a score or ranking of a characteristic related to nerverecruitment or an unwanted side-effect. Failure to obtain nerverecruitment, or presence of an unwanted side-effect, can result incontingent operations such as NiNA coaching the user to move the wraplocation, change the pressure, repeat steps for adjusting intensity andlocation, or changing other stimulation characteristics until successstimulation is obtained. In embodiments, NiNA features are designed toeducate, survey and train users about SAFN stimulation along a curatedsequence that guides them on therapy-related operations includingobtaining successful stimulation. As seen in FIG. 10e after adjustingstimulation, the user is asked to indicate one or more regions wherestimulation evoked paresthesia is experienced by manually adjusting a“x” to the corresponding location on an image. A user can be surveyed toindicate the most proximal or distal location (or both) whereparesthesia is sensed. This information can be ranked, organized, anddisplayed to assist NiNA and/or the user to determine settings for whichsuccessful nerve recruitment occurred.

In embodiments, the digital ecosystem module 50 includes software in itsvirtual module 50 a that allows a user to select (e.g., draw upon) oneor more regions of an anatomical representation of a user's body partsuch as a leg to indicate the location(s) corresponding to where theuser feels stimulation-evoked sensations such as paresthesia.Additionally, the user may be surveyed on quality (e.g., vibration,tickle, pressure) of stimulation related sensations. It can also surveya user to determine if an unwanted side-effect has occurred. If a userindicates stimulation of an unwanted area or type (e.g., calf musclestimulation) has occurred, using the anatomical map or otherwise, thendefined contingent operations occur. For example, the control module 40algorithm selects or suggests alternative stimulation settings that mayprovide improved comfort such as a set of one or more montages with ageometry that provides lower weighted or no stimulation near anon-target area (e.g., shin muscle or calf muscle), or providingnotification to a user that muscle co-activation should be avoided.

Additionally, NiNA can provide a curated sequence of alternativestimulation protocols (and associated matrix settings that result indifferent patterns of stimulation pad activation) that are cycledthrough by the system. The program cycles through the candidates todetermine which produced the largest or most distal region ofparesthesia (e.g., tingling in their toes) and/or unwanted side-effects.A user may simply experience the different stimulation montages, or maybe surveyed to indicate, through a button press or verbal input, whichof a set of stimulation settings did not produce unwanted effects.Sensed information related to at least one of SNAP and EMG data may alsobe used to assessed to create a score or ranking that is then used toadjust the stimulation montage. The successful settings are stored andcan be further evaluated by a user or selected during treatment.Additionally, protocols for which calf or other muscle activationoccurred above a defined level can be rejected from further assessment.

In embodiments, the user can rank each stimulation montage according toamount of nerve recruitment and one or more side-effects. The montageswith the highest ranks for nerve recruitment and/or lowest scores forside-effects are stored in a look-up table. Accordingly, if a set ofprotocols did not produce unwanted side-effects, and one of theseproduced the strongest rank for nerve recruitment, then this protocolwould be suggested to a user or saved for further use during a therapysession. In addition to selecting locations where paresthesia isexperienced, a user may be asked to provide qualitative, quantitative,or ranked feedback on sensation (e.g., tingling, thumping, tickling,vibrating, etc.). The data about sensory perception and side-effectsinput by users as part of a training or assessment procedure may be usedby NiNA to select a set of stimulation protocol characteristics.

FIG. 10g shows a screen 270 for providing features related to settingtreatment schedule preferences and FIG. 10h shows a screen 272 forsetting of a time at which a reminder alert is provided (which can alsobe different on different days). Additional schedules can be shown tousers and set for treatment events such as education, user surveying,remote sessions, etc.

FIG. 10f shows a screen 268 of NiNA features related to training,education, and coaching. Selecting items on the screen allows users toobtain on-demand education about nutrition and dietary choices that canimprove symptoms (e.g., screen 274 of FIG. 10i ), behavioral therapiessuch as Kegel exercises shown in screen 276 (FIG. 10j ), and educationabout the disorder being treated and its symptoms depicted as screen 278(FIG. 10k ).

In embodiments, the onboarding process 100 relies on a set of usersurvey rules created using likelihoods determined from a sample ofprevious users, or based upon results in the medical literature,demographics, medical history, and logic. The survey rules defined inthe survey module 50 f cause user responses to a first set of one ormore survey items to contingently lead to later items that have agreater chance of being relevant to a user. For example, in thetreatment of OAB, if a user provides a response to a first survey itemthat indicates nocturia is a symptom, and the subject is >65, then asubsequent survey item may probe if they also suffer from restless legsyndrome (RLS). This survey item is more likely to be appropriate sincerisk of RLS increases with age and may contribute to frequency/risk ofnocturia (or may be due more to RLS than to OAB). In another example, ifa user indicates they do not suffer from stress incontinence the surveymodule 50 f is modified so that questions about doing exercises focusedon stress urinary incontinence (SUI), or about what activities are morelikely to cause stress incontinence (e.g., laughing) are notsubsequently presented to a user. In another example, if one or moresurvey items are answered as “not applicable” by many users who sharecertain characteristics or users who have also answered a prior set ofone or more survey items in a particular manner, then that survey itemmay be omitted from questions presented to subsequent users of thesystem 10 a.

In embodiments, during an onboarding process controlled by onboardingmodule 50 e, users are surveyed 108 about therapy goals. For example,users may choose the most important therapy goal, rank their therapygoals, or be asked to rate the importance of goals such as: reduction inleaks, or pad/diaper use, reduction in number or severity of urges,reduction in nighttime or daytime frequency of voiding, reduction inbladder medication dosage needed for symptom relief, ability to delaylonger before voiding occurs, or reduction in anxiety over symptoms. Theresponses are stored by the user profile module 50 g, and the therapyprogram is then modified based upon these answers. For example, NiNAadjustments based upon the answers provided during onboarding caninclude educational content presented to a user from the referencematerials module 50 b, the survey items or user responses that are usedto track a user's therapy progress, the scores used to assess usertherapy progress 144 (which may also be used to adjust the treatmentprogram such as to modify the duration of treatment or how often itoccurs each week, etc.). Part of the progress tracking 144 includesupdating and presenting timeline information as treatment continues andusers complete (or fail to complete) treatment events and activities,according to log data information, and according to changes in symptoms.

Users who indicate they are awakened by the need to go to the bathroomat night (nocturia), may share some common behaviors or characteristics:a) Fail to decrease drinking near bedtime; b) keep a glass of water neartheir bed for drinking during the night; c) drink coffee, tea or soda atnight; d) wake up after they already have wet the bed and did not feelany urges that awakened them; e) wake up and make it to the toiletwithout leaking; f) wake up and must urinate so badly they often leakbefore they arrive at the bathroom. Alternatively, some OAB suffers maytypically sleep through the night and only experience symptoms duringthe day. In embodiments, the onboarding module 50 e may survey users toindicate which of the above behaviors/characteristics are relevant andwill then adjust therapy, surveys, or scheduled ecosystem eventsaccording to user responses.

For example, if users indicate nocturia is not a problem in step 100 ofFIG. 8b then the system may no longer ask them any questions aboutsymptoms related to that problem as part of step 104. If a user does notsuffer from nocturia then as part of step 104 the system will alsoadjust the parameters of the coaching module 50 h when surveying a userabout this symptom or may modify the progress module 47 so that trackingor assessing treatment progress will not include nocturia symptoms whencalculating any score used in assessment of progress. Alternatively, forusers who provide a positive response for items a-e as part of step 100the coaching module 50 h of the digital ecosystem module 50 will beadjusted. In embodiments, the coaching module 50 h will be adjusted sothat the system will present videos, articles, statistics or “fun facts”about nocturia as part of step 104 and can set push reminders to occurat a selected time such as “try not to drink within 2 hours before goingto sleep”. It may also suggest to a user that providing treatment atnight maybe preferable than providing treatment in the morning. Thesystem 12 may also ask users additional questions related to frequencyor severity of a symptom or behavior, (e.g., how many nights per week ortimes per night they are awakened by an urge to urinate). Educationalcontent which is tailored to modify user specific behaviors and educateusers on individual problems can serve to improve the overall therapyexperience in addition to the benefits obtained by nerve stimulation.

In embodiments users are surveyed about stress incontinence in step 100.Users who indicate symptoms of stress incontinence symptoms may besurveyed further either as part of the onboarding process or in a laterstep that is provided during treatment. When only stress incontinence isidentified during onboarding, then in step 104 a user may be informedthat the treatment may not be appropriate for them since it is mainlyintended for urge or mixed incontinence. As part of Step 104 they maythen be asked to schedule an in-person or telemedicine visit to discussthis topic further with a medical professional. Alternatively, thesystem may be configured to survey the user with additional items thatare designed to more accurately assess if a user suffers from mixedincontinence. In this latter case, a user can be informed that bothstimulation and Kegel exercises or bladder drills should be included inthe therapy program to properly treat their symptoms, and both promptsand education can be scheduled by the coaching module 50 h as part ofthe therapy. Further, indication of mixed incontinence may cause aschedule in the coaching module 50 h to be adjusted to provide morefrequent remote sessions (or prompts to schedule sessions) with a nursetechnician who will have access to the patient profile record wheremixed incontinence is noted as a problem which should be treated andassessed during treatment.

In embodiments, during an onboarding procedure provided by theonboarding module 50 e or provide later by the survey module 50 f, thesystem 12 surveys users about how bothered they are by various symptoms.This can include scales related to, for example, how severely symptomsaffect a user's lifestyle choices or interferes with how they wouldotherwise live their life. The user's responses related to bother may becompared to a user's scores for survey items about symptom severity. Ifscores for symptom severity do not correspond to scores for symptombother, then the system may operate contingently. For example, it maysurvey users further about why a bother score is divergent from symptomseverity. A user may be surveyed to determine if they are not botheredby a symptom due to: a) a belief the symptoms are part of normal aging,b) user habituation to long-term symptoms they have gotten used to, c)user adjustment/adaptation of daily living so symptom present lessbother, etc. If symptom severity and bother scores are divergent, thenthe system can present selected educational material which may beadjusted based upon user responses to these survey items. The system 10a may also adjust progress tracking 114 performed by the progress moduleso that improvements in bother scores are tracked and presented to apatient instead of scores that are directly related to symptoms. In thatmanner a user can see progress as measured by improvements in how much asymptom bothers them, even if there are small changes in the symptomseverity itself. Bother reduction can also be used as a treatment goal.

In an embodiment, survey responses are evaluated to indicate if a userhas a profile which does or does not respond well to stimulationtherapy. The system 10 a can obtain and assess the user profile dataeither during onboarding 100 or as part of a website that users enterdata into prior to starting therapy. Data for a population of priorusers of the therapy is used to identify subpopulations of users whoeither benefit or tend not to benefit from the stimulation therapy, orwho may need a longer induction period. For example, a user may bequeried about prior or concurrent treatments (e.g., Botox, medications,other type of electrical therapy such as pelvic floor electrotherapy forstress incontinence, Kegels) and symptoms. Users can also be surveyedabout previous or current OAB medication (e.g., oxybutynin, tolterodine,darifenacin, fesoterodine, solifenacin, solfenacin, trospium,mirabegron) as well as dosage. Surveying may also include othermedications for conditions such as hypertension, anxiety, depression,headache, migraine, pain, etc. A user can also be surveyed aboutcomorbidities such as diabetes, hyperglycemia, hypertension, metabolic,immunity, inflammation, or other disorders. The patient education andtreatment can then be modified according to the user profile data. Ifcertain drugs have been shown to increase risks of exacerbating OABsymptoms, then the user can be informed of this risk and provided withadditional education. In embodiments, the system, stimulation protocolsand NINA support are configured to provide treatment of any of theconditions and comorbidities disclosed herein rather than being designedto treat OAB. Further, in embodiments these are designed to treataddiction or substance abuse.

In an embodiment, if a user indicates they have been prescribedmedication to treat OAB or another condition then the ecosystem surveysa user if they want the system to provide medication reminders as partof coaching 140 in addition to those provided for stimulation treatment.Medication reminders can also require user input upon taking themedication and the system can track compliance for both medication andtreatment stimulation. When a drug or other treatment is provided incombination with SAFN stimulation, then this can be tracked, assessedfor compliance and provided with reminders.

Onboarding and Therapy Methods.

The steps disclosed for FIGS. 8a, 8b, and 8c , and other methods,stages, and programs disclosed herein, can occur as isolated steps, berepeated, and can incorporate steps shown in other methods. As FIG. 8billustrates, an embodiment of a curated treatment program that includesNiNA features provided by a digital ecosystem 50 which first onboardsusers 100 and then guides them during therapy 130 to provide a userfriendly neurostimulation therapy experience and improved therapybenefit.

In embodiments, as part of step 100 a mobile software companionapplication “App” 21 is uploaded to a user device 20 a. An Onboardingwizard of the App 21, which constitutes part of onboarding module 50 e,provides a guided/structured sequence of operations that serves toonboard a user (e.g., FIGS. 10a-10k ). Interactive displays allow a userto set up preferences used by the software programs that provide thetherapy. Onboarding welcome operations introduce/explain 102 topics suchas the medical disorder and provide an overview of the therapy andtreatment timelines (e.g., FIG. 9b, 9c ). This can include graphicallypresenting a user with a timeline of therapy events scheduled in thefuture including patient surveys, education events, at least one datefor transition from induction to maintenance therapy. Onboarding 100provides instructions and training on the neurostimulation treatment,proper device positioning, how to adjust and determine the correctamplitude and stimulation montage, and reviews additional features ofthe NiNA ecosystem.

In embodiments, the introduction process 102 includes steps such as: a)operating the app 21 to setup a user account with contact and billinginformation; b) communicate securely with the neurostimulator 12 toexchange data including ID data for the device 12 and matrix 14; and c)communicate all data related to the onboarding process to user accounton a remote computer 20 f.

In embodiments, onboarding provides an overview of the therapy 102(e.g., FIGS. 10a,10b ) includes patient accessing libraries ofeducational content on their disorder and symptoms (e.g., FIG. 10k ),various features available as part of the therapy (e.g., FIG. 10d ), howto provide treatment in an at home setting (e.g., FIG. 10c-f ).Onboarding introduction 102 can include video content (e.g., deviceset-up and use, how to detect and rate stimulation evoked sensations oractivity, how to adjust, assess, and select good stimulationparameters), access to weblinks, review of reference materials, and/or aremote telemedicine session. After instructional videos are shown instep 102, concepts are reinforced and users are trained 104 on aspectsof therapy and are guided with step-by-step screens for attaching thedevice to their body and setting up the system for first time use. Theinstruction can also include diagrams, animation, instructions presentedvisually on topics such as how to adjust the stimulation parameters toproduce nerve recruitment.

Training 104 can include screens that permit users to adjust theintensity (e.g., FIG. 10d ) and location (e.g., FIG. 10f ) of thestimulation using NiNALocate protocols and may include obtaining userfeedback about stimulation evoked sensations (e.g., FIG. 10e ). Whilemuscle activity may be an unwanted side-effect for SAFN stimulation, forother nerves successful nerve recruitment involves evoked muscleactivity (e.g., using PTN stimulation) or a decrease in tremor magnitude(e.g., when treatment is provided for a tremor or motor disorder), orother measure related to treatment of a different disorder. In theseother treatments, users are be surveyed about both wantedstimulation-evoked changes and unwanted side-effects.

For SAFN stimulation, training step 104, can include instructions andtraining exercises on a) an overview showing a user providingstimulation; b) how to properly place the matrix on the leg (e.g., FIG.10c ) and adjust the stimulation strength (e.g., FIG. 10d ) andlocation/geometry (e.g., FIG. 10f ) of the stimulation field to targetthe SAFN and provide sufficient nerve recruitment; and, c) how tocontrol the electrical stimulation to achieve a strong but comfortableparesthesia sensation from SAFN stimulation as well as asking the userto describe/confirm the paresthesia (e.g., FIG. 10e ), and guiding theuser until improved nerve recruitment is obtained. Controllingstimulation protocol parameters during training may also be used toavoid unwanted effects such as decreasing or avoiding: a) concurrentmuscle stimulation (e.g., calf, leg, or foot muscle) due to unwantedspread of the electrical field; b) the sensation of pain from the skinunder one or more stimulation pads due to non-SAFN cutaneous nerverecruitment; and, c) the need for using higher amplitudes to recruit theSAFN. The training step 104 may also include asking users about theirperception of stimulation including: a) qualifying (e.g., tingling,pinching, etc.) the sensation of paresthesia; and, b) quantifying thestrength of the sensations (e.g., light, strong, very strong, e.g., FIG.10e ; or rating strength on a scale from 1-10, with 10 being “barelytolerable”, etc.) and providing information about location(s) or areasof skin stimulation or paresthesia.

In step 106, contingent operations are defined which occur based uponthe feedback on the effects of stimulation. For treatment using SAFN, ifthe user does not indicate they feel sufficient paresthesia (possiblyindicating lack of nerve recruitment) or have an unwanted symptom thencontingent operations are defined to guide a user to correct a problemso that improved therapy may be provided. For example, in step 106 auser is contingently provided 106 with further instructions, such asbeing asked to make an adjustment and repeat the process until theysuccessfully stimulate the target nerve, changing parameters if they areexperiencing unwanted muscle stimulation, switching to the other leg,changing placement on the same leg, or starting a remote session forguidance by a medical professional: however, training and feedbackallowing correct device usage and setting of stimulation parametersshould often be supported purely programmatically. During training, whenevaluating or establishing characteristics of the stimulation protocolthat relate to, for example, the stimulation amplitude or field steeringthe user may be contingently guided by their answers to survey items.For example, the device may survey the user by presenting the questionon the screen “Do you feel any stimulation yet” and if the user response“no”, then the device may contingently instruct the user: “pleaseincrease the intensity”.

In step 108 users are surveyed about various topics including theabsence/presence and characteristics (e.g., frequency, timing andseverity) of symptoms. In embodiments, users are asked about theirsymptoms, to provide information about their therapy goals, medical andtreatment history and other relevant information. In addition to beingsurveyed about their symptoms they may be asked to review educationalinformation that is selected based upon their reported symptoms, medicalhistory, etc. Further, all user responses are stored within and/orprocessed to adjust the user profile. The user profile data in turn canbe used to adjust treatment parameters and events. For example, a user'stherapy goals can be used to adjust educational information that isprovided, measures that are tracked over time, survey items presented toassess symptoms or treatment benefits, progress that is tracked andgoals that are achieved. If a primary treatment goal is to decrease padusage then treatment characteristics, such as behavioral exercises, thatare selected will be different than those selected if the goal is todecrease nocturia.

In embodiments, onboarding operations contain a logic tree structureand/or algorithms that utilize rules, artificial intelligence, machinelearning with or without the use of neural networks, and other adaptivestrategies to ask questions and adjust treatment to improve theuser-friendly experience. For example, if a patient responds to a surveyitem 108 by indicating no prior prescription of OAB medication, then asurvey list requesting the user indicate OAB meds used previously willbe contingently skipped 110 according to a survey logic rule operated bythe survey module 50 f. As another example, if a user indicates duringsurveying 108 that the largest reason for seeking therapy isincontinence, then subsequent survey items on that topic arecontingently selected 110 to be presented. The survey module of thesystem will also contingently 110 decrease or omit survey items thatobtain user input about symptoms which the user reports as “not aproblem” (e.g. a rule is defined to flag associated survey items sothese are skipped during therapy). Additionally, if surveying 104indicates that a symptom is not present, or a “bother score” is low fora particular symptom, then information about that symptom may not betracked, displayed, used to assess changes in symptom severity, or goalassessment of a patient.

In an embodiment, users input data related to their medical conditionusing logic tree menus that enable easy logging of a medically relevantevent which includes quantifying or qualifying at least 2 relevantcharacteristics. For example, for a leak event or bladder toiletingevent the system requires users to input a combination of two or morecharacteristics such as subjective urgency data and leaked amount. Theleak event urgency may first be selected using a menu bar as low,medium, or high urgency. After a user moves their finger vertically toselect one of the candidate choices, the user subsequently slides theirfinger to the right to select the second characteristic of the event.For example, this action invokes a further menu tree which comprises asecond set of candidate choices related to the second characteristic,which in this example is an amount. The second set of candidate choicesmay include small, medium, and large amounts. In order to finalize thelogging of the two characteristics of the event, the user can indicatethe selection has been made through a gesture such as a screen “tap”.This input method requires the user to characterize the event for atleast two (or more) dimensions.

In step 110, survey response data is used to create baseline symptomscores. In embodiments, these data are used to contingently adjust whichsymptoms will be evaluated as therapy continues, when symptoms will beassessed, how these will be scored and tracked, how therapy progress isassessed, and how treatment success is defined. For example, if a userdoes not report any problem with nocturia then that measure may not beused to evaluate treatment progress.

In step 112, users can provide user preference information for therapyparameters such as therapy event and patient reminder schedules (e.g.,FIGS. 11a /11 b). Schedules are set for different therapy eventsincluding days, times and durations for providing treatment stimulation,user education, surveying about symptoms, and other treatment protocolevents.

In step 114, these preferences are used to contingently adjust thetherapy schedule parameter values so the system prompts the user atcorresponding dates and times (e.g., days each week).

In step 116, the user is surveyed to define the characteristics of anyalerts that will be provided according to user preference. Patientalerting includes using sounds, push notifications, calendar entries,e-mail, etc.

In step 118, user provided data and preferences for alerting are used toadjust the alerting protocol parameters which will be used by the systemto provide the treatment regimen.

In step 120, the system surveys the user to obtain information relatedto skin sensitivity and to assess the presence of user characteristicsthat increase the risk for adverse reactions related to the skin “skinevents” (e.g., tearing, bruising, skin irritation).

In step 122, the system then contingently adjusts operational parametersin relation to 1 or more user answers or by a composite skin risk score.The adjustments can include providing or instructing users about userbehaviors, or adjusting the therapy protocols, which can decrease risksof therapy related skin events. Step 122 can lead to operations definedfor step 176 of FIG. 8 c.

In step 124, data obtained from user onboarding operations are used tocreate a patient profile and to contingently adjust 126 associatedtherapy regimen characteristics. This includes adjusting operation whenproviding various system features so these occur according to theinformation and preferences stored in the patient profile.

“Restore” Induction and “Maintain” Maintenance Programs.

The onboarding wizard provides the first steps in establishing a curatedinduction-treatment “Restore” program of the system 10 a. Treatmentprovided by the system 10 a can be guided, non-guided, or a combination.Even when treatment is guided using the Restore program, the user mayalso access reference materials or complete surveys in an unscheduledon-demand manner.

If a user indicates they will use the system 10 a in a non-curated mode,or if a set of features of the Restore program are set asnon-customizable, then during onboarding a user may skip (or is notpresented with) adjusting parameter values for features such asdays/times used to survey the patient. While typically users are guidedthrough a prespecified onboarding process 100, this may includeoperations that occur contingently due to user input. Onboarding allowsthe creation of a patient profile 124 with user data and preferencesthat are used to adjust parameters of a curated treatment regimen withscheduled events such as treatments, patient education, symptomtracking, etc. The Restore induction program is followed by a “Maintain”therapy regimen of maintenance treatment. Events of the curated therapyregimens are triggered when a predefined date-time matches the datetimevalue of a real-time clock of the control module 40, due to usercommands, due to commands received by a remote user device 20 f, orother component of the system 10 a.

Conventional clinic-based treatments using percutaneous posterior tibialnerve stimulation (PTNS) typically include a 12-week induction period ofweekly stimulation. This is followed by a maintenance period withtherapy sessions occurring about once per month. Prior to work done bythe inventors, the interval required to provide sufficient inductionwith daily transcutaneous SAFN stimulation was not known. The Inventorsperformed clinical studies and results supports a 28-35 day period is asuitable induction interval for treatment of OAB with transcutaneousSAFN stimulation.

More specifically, in a study with >50 OAB patients (^(˜)50% refractory;^(˜)50% drug naïve) a daily at-home SAFN stimulation session lasting 30minutes showed that a OAB therapy benefit was improved if at least a 22day interval was used, with most having an induction interval below 35days. Not to be limited by theory, a meta-analysis of several clinicalstudies recently conducted by the inventors support a 28 day Restoreprogram was sufficient for a majority (e.g., 70%) of patients. Whilesome patients showed improved symptoms by 2 weeks, using an inductioninterval of 21 days or less was found to have long term disadvantages.For example, a shorter induction interval of 15-21 days compared to >21days led to a lower rate treatment success and smaller symptomimprovement at 90, 180, and 360-day timepoints. Defining the Restoreinduction treatment program to last between 22 and 35-42 days, andpreferably 28-35 days is preferred. In embodiments, 28 days may becontingently extended such as to 35 or 42 days if a minimum definedimprovement is not obtained by 28 days or if a patient chooses or allowsa 42 day induction period. The extension in the induction period isaccompanied by additional pre-defined scheduled events such as usersurveying, coaching events, positive reinforcement messaging, and goaltracking.

An example of advantages for a 28 to ^(˜)35-day induction periodcompared to a shorter 15 to <21-day induction period is shown in FIG. 13(objective OAB measures; subjective measures exceeding a clinicallymeaningful change). The table shows more consistent benefits at 180 and360 days for the >21 day induction group. Not to be limited by theory,these data support, for the first time, that a SAFN daily inductioninterval can be reduced from 12 weeks used with clinic based PTN to^(˜)28 days while providing good efficacy even 1 year later whenfollowed by a maintenance regimen: even if symptom improvement for auser occurs quickly, induction periods <21 days appear to yield lowerlonger-term therapy benefit.

While these results were derived with daily SAFN stimulation, these aresignificant for minimum treatment protocols for other disorders whenperipheral stimulation is used to promote neuroplastic changes. This mayalso be relevant for OAB treatment with other peripheral nerves of theleg such as PTNS. The proposed schedules for induction and maintenanceare applicable to embodiments.

In embodiments, the induction protocol is preferably defined to occurdaily for at least 30 minutes. The protocol may also use 5 or 6 days asa minimum to meet compliance criteria. The protocol can also permit orrequire more than one session per day (e.g., at morning and at night),or be realized as two shorter treatment sessions of 15 minutes each, oruse longer therapy sessions (e.g., 1 hour). When providing more than 30minutes of stimulation per day the Restore program may be reduced to ashorter interval than 28-days.

In embodiments, the Restore induction, can be contingently extended 136at least once by 1 to 4 weeks if users have not met one or more minimumsymptom benefit criteria after a given interval, or if they areotherwise willing to extend to increase therapy benefit. A longerinduction interval can be set in the patient profile informationestablished during onboarding or can be selected at the end of a definedinduction interval.

The interval can contingently be adjusted to use a longer stimulationsession (e.g., 60-90 minutes), and multiple daily stimulation sessions(e.g., morning, afternoon, and/or evening) during the original orextended treatment interval. At the end of any period defined for theRestore program, a user (who has not obtained a minimum treatmentbenefit or for other reason) may be asked to choose to, for example: a)increase the average therapy session length (e.g., from 30 to about 45,60, or 90 minutes); b) increase the number of stimulation sessions perday (e.g., 1, 2 or 3); c) increase both the length and number oftreatment sessions below a permitted limit; and/or d) increase theinduction period to one of several permitted intervals. Alternatively,the induction protocol may be designed to contingently increase thetreatment session length, number, or both based upon user data.

In an embodiment, during onboarding, a patient can choose an inductioninterval of 28, 35, or 42 days, a treatment interval of 30 or 60minutes, provided across one or more sessions each day. Veryenthusiastic users may select a 42-day interval with up to 60 minutes ofstimulation each day. It is likely that longer than 60 minutes would notprovide further benefit and could increase the risk of skin events. Formost patients, using more than 42 days and 60 minutes of strong butcomfortable stimulation appears to be sufficient to provide therapybenefit when stimulating the SAFN in the treatment of OAB.

During the maintenance period scheduled stimulation, or stimulationprovided using an on-demand basis by the user, may be designed to occuronly 1-3 days each week. In an embodiment, a module such as theonboarding or compliance module will restrict the scheduling orprovision of maintenance stimulation, or will at least provide a warningmessage, according to at least one of several different types ofsequential stimulation criteria, such as:

a) hour-based criteria can restrict the number treatment sessions thatare allowed to be scheduled or provided within a selected time windowsuch as 12 hours. This type of criteria may also be defined acrossdifferent calendar days (e.g., a user cannot provide a treatment sessionat 11 p.m. on Tuesday and then 7 a.m. on Wednesday morning);b) intraday criteria may restrict the amount of stimulation (e.g., 30minutes) allowed to be scheduled or provided on a single calendar day;c) interday criteria may restrict the amount of stimulation that isscheduled or provided on different calendar days.d) intraweek criteria may require that the user selects or providesstimulation on non-sequential days that have at least one interveningday. Other criteria may require that if the user selects two days forscheduled stimulation that are adjacent (e.g., Monday and Tuesday) thatthe 3^(rd) scheduled treatment is non-adjacent and separated by at least1-2 days (e.g., it is allowed on Friday); and,e) interweek criteria requires that days on adjacent weeks must bedistributed to meet an interweek criteria such as 3 days cannot bescheduled or occur within a 3-day period for two sequential weeks. Forexample, a user cannot schedule or provide stimulation on Mon, Sat, andSun on a first week followed by Monday Tuesday and Wednesday on thefollowing week.

These criteria deter users from providing treatment stimulationaccording to schedules that “clump” stimulation into clusters ratherthan distributing these more evenly in time. In an embodiment, if usersprovide stimulation that violates a sequential stimulation criterion,then the stimulation session is not counted toward meeting a minimumamount of stimulation for a given interval. A contingent operation maybe triggered as if the therapy stimulation did not occur (e.g., patientreminders may still be provided contingently to meet a therapycompliance criteria). Additionally, the criteria can be defined torequire a certain amount of stimulation occurs within a selected timeinterval.

In embodiments, the Restore treatment program is configured to provide aschedule of therapy events with a timing that is set according to thedefined induction interval such as 28 days. For example, a symptomtracking protocol is used which first provides a baseline survey of apatient during onboarding. Alternatively, 1 or more baseline surveys arepresented to the user before, during, or after defined therapy sessions(e.g., during or after the first 1 or 2 treatments of the first week oftherapy). The Restore treatment program is then programmed tosubsequently survey a user at later times such as at 2, 3 and/or 4 weeksto measure symptom severity. The progress module 47 assesses changes insymptoms by comparing the later survey results to the baseline surveyresults. Further, the Restore treatment program can report changescalculated by the progress module 47 for at least one of a user'sbaseline symptoms and symptoms evaluated at the later time (see FIG. 9a).

While these other events can occur at fixed times, these may also beadjustable and users can schedule the activities and events related tothe therapy regimen. For example, survey items can be set to bepresented on a certain day, or on a defined schedule such as every otherday or week, etc.

The Restore treatment program of the App 21 can operate a progressmodule 47 to store one or more treatment goals defined by the system, oruser-defined, such as reducing a symptom by a selected amount. At leastone treatment goal may be selected by prompting a user to choose thesymptom for which the patient most desires to see improvement (e.g.,Nocturia), or choosing a goal for a symptom (e.g., reducing the numberof nocturia events by 1 or 2). The progress module 47 can presentencouragement messages (i.e., provide a positive outcome treatmentresults) to a patient when a goal meets 1 or more defined thresholds(e.g., “Congratulations your nighttime events have decreased by X %”,where ‘X %’ is set to be at least of a set of defined percentages).

Coaching.

The coaching features of the NiNA digital health platform can be used toimprove outcomes, increase user engagement, improve adherence, decreasedrop-out or undertreatment, and save time, effort, and cost for medicalpractitioners. Coaching enables NiNA to guide and remind users so thatappropriate user activity occurs. This disclosure has provided manyexamples of how the Restore and Maintain programs provide coaching suchas user training on the therapy and scheduled events that are defined aspart of therapy. In embodiments, NiNA provides therapy benefitindependent of that derived by the stimulation therapy, or whichsupplements or supports the neurostimulation therapy. For example,behavioral coaching can provide alerts for scheduled toileting ormessages timed to discourage drinking too soon before bed.

Coaching 140 can include providing reminders and nudges and providinginformation relevant to a patient's treatment, which is an importantpart of the user experience and can be especially convenient to presentduring a treatment session. These serve to support the user towardssuccessful treatment and may include, for example, reinforcement viapositive language and accolades, reminders for re-charging their device,and informational “snacks” to be digested before, during, or aftertreatment. There are also reminders provided by the coaching module thatnotify a user when it is time to resupply/replace their stimulationmatrix pads ensuring clean/usable pads that provide effective treatment.Coaching can also cause a user or selected caregivers to be sentnotifications about usage, symptom changes, non-compliance, etc. toencourage/monitor usage.

Coaching is provided as part of Restore and Maintain treatment programsto reinforce correct treatment. The treatment program of the system caninclude behavioral training and prompting as part of coaching 140 thatincludes use of individualized toileting schedules for scheduled orprompted toileting. In an embodiment, the system simply alerts anindividual on a defined schedule to prompt toileting. The system mayalso alert a caregiver or nursing station as part of a scheduledtoileting program. The prompts may also be tied to activities such astime going to bed, or typical time when a resident “wets the bed”, sothat the toileting occurs prior to a potential episode of incontinence.The toileting program can be related to preventing urinary or fecalincontinence or both. The program can also be tailored to be morefrequent in cases where a user has comorbid conditions such as a urinarytract infection or ulcer related to moisture of the pelvic area.

In an embodiment, a data log is maintained that includes all therapyevent types (stimulation sessions, scheduled survey questions,behavioral exercises such as Kegels etc.). The compliancecharacteristics for each event are defined and user activity is logged.For example, a stimulation session may require that a subject providesat least 30 minutes of stimulation using a minimum amplitude level), asurvey session may require at least a minimum percentage of survey itemswere responded to by the user, a behavioral exercise may require thesubject conduct the exercise for at least a minimum amount of time 5minutes. The extent to which a user meets the minimum criteria of anactivity determines if the activity is logged as compliant or not. Inaddition to defining event compliance characteristics, complianceevaluation rules are defined for each therapy event. For example, acompliance evaluation rule may require that 3 sequential stimulationsessions (or 3 stimulation sessions within a two-week period e.g., 3 outof 14) are missed before a non-compliance event is logged or flagged bythe system, whereas for a different event the rule may be less lenientand even 1 event being missed triggers action.

When non-compliance occurs then coaching may include proposing asubstitute event. For example, a substitute treatment event may be usedto meet a compliance criterion when defined by one or more evaluationrules. For example, if a user misses two 30-minute treatment sessions,then the user may be prompted or allowed to meet a treatment eventcompliance criterion by providing 60 minutes of stimulation (instead of30), if this is defined as an acceptable substitute treatment event. Inan embodiment, the compliance evaluation rules may allow a selectednumber of substitute treatment events to occur within a definedinterval, such as 1 month before a non-compliance action contingentlyoccurs such as scheduling the user for an in-person telephone call witha medical professional.

In an embodiment, at least one of: a) the number of substitute eventsper defined interval, b) a compliance evaluation rule and/or c) acompliance notification rule is defined as a function of at least oneof: the induction period, the maintenance period, whether a patient hasshown a minimum improvement or decrement in symptoms, as defined by adoctor, or an alternative defined condition.

In addition to logging, calculating, and displaying trend data relatedto symptoms, which allows users to track progress, the data and summarystatistics related to all therapy events can be displayed to a user toincentivize compliance and increase user engagement in their treatment.

In addition to user-scheduled events, information about a disorder orspecific to a user's symptoms can be provided as part of coaching toperiodically educate the user. For example, “pelvic floor fun facts” canbe personalized for a user. For example, a user's summary statistics canbe calculated from logged data including, for example, the averagenumber of bladder voids per day or the average amount of time betweenbladder voids and this can be presented in the context of what may beseen for the disorder (or the range seen in other users of system).

In addition, to incentivize a user, the system may present messagesabout compliance or improvement in symptoms such as calculating thenumber of voids per day each week for a month and presenting a messageto user about improvement if such improvement meets a defined threshold.For example, a message may be displayed if urinary urgency is ratedlower for a recent 1-week window compared to the average urgencyreported by the user for the first week of therapy or for a baselineperiod of 1 week prior to starting therapy.

In an embodiment, the Restore program presents a user with a set of 3-10survey items once or twice per week to assess symptoms. Changes in auser's symptoms compared to their baseline symptoms that meet atreatment criterion can trigger positive outcome treatment events suchas providing the user with a graph of progress and/or an encouragingmessage. Additionally, if changes from baseline fail to meet a treatmentcriterion, then negative outcome treatment events can be triggered suchas: a) suggesting a remote meeting with a nurse practitioner, b)extending the Restore period for an additional period, or c) suggestionto a user that the treatment duration be increased to 1 hour a day for aselected interval (serving as booster treatments).

In embodiments, the Restore program can be used to provide, supplement,or substitute the therapy of an implantable device. For example, awearable device is used to provide induction therapy for a period of >21days prior to an implantable device being implanted which then providesmaintenance therapy that occurs less often (e.g., 2-3 days per week).Alternatively, an implantable neurostimulator may be implanted and thepatient allowed to heal before starting a period of induction therapyusing a Restore program. Alternatively, after implantation a wearableneurostimulator or a combination of the external and implantedneurostimulators can be used by the Restore program. The schedule whenthe implantable device provides stimulation can be used to adjust theschedule of stimulation provided by the external device. For example, ifthe implantable device provides stimulation 2 days a week, thestimulation scheduled provided by the wearable can be adjusted so thatstimulation is provided on the remaining days so that daily stimulationis provided during induction. The Restore program is adjusted to accountfor the stimulation schedule of the implanted device.

The Restore program provides coaching using a drip-feed of informationat scheduled times. The drip feed algorithm is “smart” and willcontingently show information on a symptom (e.g., nocturia) only if auser indicated presence of that symptom during user onboarding or ifthey have a symptom score for that symptom which indicates a problem andwhich exceeds a defined threshold.

In embodiments, the Restore program provides behavioral therapyexercises that have traditionally been delivered in-person by a pelvicfloor physical therapist or nurse practitioner. This coaching aspect ofsystem can undergo clinical trials to show independent or additionalbenefit to the neurostimulation without the ecosystem support and allowsthe software to be certified as a digital therapeutic, “software as amedical device”, or a “software-based treatment” which may be separatelyprescribed before being activated as a feature.

Digital Ecosystem, Telemedicine, and Remote Management of Therapy.

In embodiments, a curated treatment program includes features providedby a digital ecosystem such as: a) computer assisted coaching 140 ofbehavioral and educational activities and training; b) computer assistedtherapy (e.g. cognitive-behavioral) to assist with, for example, forre-training of unwanted emotional states such as anxiety related to adisorder by steps 148 or 140; c) scheduled or event based presentationof information that is relevant to a disorder or unwanted symptoms bystep 140; d) access to a library of reference information by step 156;e) computer assisted patient surveying and symptom assessment by step142; f) progress tracking by step 144; f) information about behavioralexercises including video routines for guiding the exercises by step140; g) information on nutrition or supplements that may improveunwanted symptoms of a disorder by steps 140 or 146. The features can beprovided according to user request 156 or due to a schedule 131 definedin the treatment program which are invoked as part of step 134 and usepatient prompts 138 that remind a user to perform an activity. Remindersare presented to users 138 to improve treatment stimulation complianceaccording to a predefined, or user defined, treatment schedule or topromote other user operations, behaviors, or activities that can benefittreatment.

The ecosystem parameter values related to the provision of therapy canbe approximately fixed, or may be initially adjusted according topatient profile preferences and then be further adjusted according totherapy failure or progress assessed at one or more timepoints.

Onboarding has already been disclosed and is used to create a patientprofile which can be used to adjust selected subsequent treatmentregimen characteristics according to patient data and preferences. Asshown in FIG. 8b , a user's answers to survey questions provided atbaseline in response to a user evaluation program as part of onboardingare obtained 100 and assessed (by software routines of the onboardingmodule 50 e) to create a user profile 102 stored in the user profilemodule 50 g. The system then contingently adjusts its operation 104 inrelation to the user profile according to a set of user profile rulesdefined in the user profile module 50 g. In embodiments, the userprofile rules can cause adjustment of survey items presented by thesurvey module 50 f, symptoms that are tracked and used to calculatetreatment progress scores (by the progress module 47) so that these areadjusted based upon, for example: a) patient baseline characteristics ofthe patient profile (e.g., medical history, disease state/severity,symptom bother assessment, etc.), and/or b) user input about whichtreatment outcomes are most important, and c) the level of desiredinteraction with the system that has been indicated by a user. Forexample, the survey module 50 f can present a user with survey items andrequest the user select whether reminders about stimulation therapy aredesired or not. They system can then operate upon the user response datato adjust the frequency of patient education/coaching provided by thecoaching module 50 h.

FIGS. 9a to 9k show examples displays selected and/or provided by thedigital ecosystem module 50 of the system 12 during treatment. Anembodiment of the Restore program uses the features provided by thesetop-level screens to provide curated therapy. Each screen represents adifferent feature category of the curated therapy. Some example featuresinclude the following screens: FIG. 9a showing screen 236 providingsetting features that allows users to adjust settings of the program aspermitted, FIG. 9b showing screen 238, provides an onboarding featureand provides educational content to a user, trains users on providingthe therapy, screen 240 shown in FIG. 9c provides explanation offeatures of the treatment stages and schedules, the screen 242 shown inFIG. 9d provides control features, including field controls forintensity and matrix location, the screen 244 shown in FIG. 9e providesuser input features including anatomical surveys which can confirmcorrect treatment, the screen 246 shown in FIG. 9f provides featuresrelated to monitoring and showing compliance, the screens 248 and 250shown in FIGS. 9g and 9h provides features related to user input,display and tracking of symptoms, the screen 252 shown in FIG. 9iprovides features related to tracking progress, the screen 254 depictedin FIG. 9j provides features of providing positive feedback and goalannouncements as part of coaching; and the screen 256 shown in FIG. 9kprovides features of informing users about advancing to a new stage ofthe treatment regimen.

The program can track user compliance in performing scheduled therapysessions and can provide reminder prompts as part of coaching 140 usersto perform a therapy session according to their selected preferences(e.g., reminders can be sent by e-mail, phone texts, and/or by pushnotifications, as well as provided by auditory or vibration alertsignals). During the course of treatment, the program promotescompliance by providing alerts, monitoring, storing/tracking, assessing,and displaying compliance. For example, the program shows usersscheduled therapy sessions vs. actual history of therapy sessionscompleted by the user (e.g., FIG. 9f ).

FIG. 9a shows an embodiment of menu screen that is displayed by a userdevice 20 a that allows a user to select different features of theecosystem. The menu includes items which allow a user to view orinteract with the following features: a user profile for letting a usercreate or “log into” an account which contains user data including userprofile information; a) a home screen which provides tiles for accessingdifferent areas of the ecosystem and having information about thetreatment such as how many days a week they should stimulate and thecurrent treatment number; b) a treatment screen that enables startingand controlling a treatment session; c) history screens which displayinformation such as days where stimulation was provided or missed aswell as treatment compliance information, statistics or scores,timelines or calendars showing days on which treatment was or will beprovided or schedules of other events such as completion of usersurveys, education, and scheduled days/times for remote sessions withmedical professionals; d) a trends screen for showing trends in scoresrelated to symptoms, bother, or goals; e) a “learn” screen that providesa starting point for accessing educational content including a digitallibrary of facts and videos; f) a support screen that allows a user tocontact technical or clinal support resources via remotetechnical/medical assistance, as well as video tutorials, user guidesand instructions related to system use; g) a digital store havingshopping cart functionality; and, h) a settings section for allowingusers to view and adjust settings related to the therapy.

The system may also evaluate users for those with nutritionaldeficiencies due to improper caloric intake and nutrients andsupplements can be suggested by the coaching module or ordered using theApp 21, as also done for absorbent pads, replacement stimulationmatrices, etc. These can also be provided on a scheduled basis as partof a monthly paid subscription of the NiNA service.

Although the menu of FIG. 9a allows a user to select different featuresof the ecosystem or provide treatment, in a preferred embodiment, theApp 21 software typically guides a user through an onboarding and thenprovides a guided experience wherein the user interacts with selectedportions of the program on a scheduled basis according to a predefinedtreatment regimen. In an alternative embodiment, the predefinedtreatment regimen (including a treatment schedule) is adjusted basedupon at least one of: user preferences, changes in symptom severity, anduser compliance.

One selection of the menu is “Treat” which can take a user to thetreatment screen shown in FIG. 9d . Instead of setting the stimulationparameters using the controls, the user can select an option “user priorsettings”. In embodiments, the control module 40 of the device 12 (oruser device 20) permits users to store therapy settings (e.g.,stimulation or user notification parameters) according to userpreference. Settings and parameter values may be hard-coded or selectedand adjusted by the user. Additionally, the system may reuse settingspreviously selected for stimulation treatment by a user includingparameter values for stimulation signal characteristics (e.g.,intensity, pulse width, and frequency range), and stimulation montagesettings (e.g., defined weight values for combinations of activechannels that are defined as anodes and cathodes). For example, if auser opts to use previously stored parameter values of a therapyprotocol then when a treatment session starts the control module 40operates the stimulation module 42 to cause the amplitude of stimulationto slowly increase over an interval such as 5-15 seconds to the amountused in the prior therapy session. The system “ramps”, or transitionsotherwise, into the same stimulation protocol parameter values used atthe end of the prior treatment session including operating thestimulation matrix in a selected manner.

FIG. 9b shows a sample introduction screen provided to a new user aspart of an onboarding program introduction 102 defined in the onboardingmodule 50 h. The screen displays an instructional video selected fromthe reference module 50 b that is narrated by a clinician and provideseducation about a peripheral target such as the SAFN, discusses themechanisms of action for treatment of a disorder, includes a lesson withinstructions on how to apply the device correctly to stimulate thetarget nerve, and includes other information that introduces a user tothe therapy such as how to use the stimulation matrix and modifystimulation parameters.

FIG. 9c shows an example of predefined treatment regimens. These includea curated “Restore” program which provides initial induction stimulationon a more intensive schedule (e.g., daily or longer sessions), and a“Maintain” program which provides a less intensive program of therapymaintenance (e.g., every other day, or 2-3 days a week, or shortersessions). In an embodiment, both the Restore and Maintain programs arestructured to guide a user to provide therapy according to a pre-definedregimen. However, in embodiments a user is permitted to customize theprograms according to a set of permissions of allowed adjustments andranges that characterize scheduled events.

FIG. 9d shows a Treatment (“Treat”) screen, with a timer and controls.The bottom of the screen provides a location for providing notificationsduring a therapy session that prompt a user to engage in various typesof treatment events such as viewing educational content or completingsurvey items. The screen also provides control of a stimulation montageincluding stimulation strength and location.

FIG. 9e shows a screen where users are surveyed to provide theanatomical location of stimulation evoked paresthesia and may befollowed by screens surveying the strength and quality of theparesthesia.

FIG. 9f shows a history screen with treatment calendar having icons thatinform about provision of treatment and compliance. The screen mayinclude notifications containing compliance scores, progress updates,reminders, or encouragement (e.g., “Excellent Job”; “You still have asurvey to complete”) that can be presented at the top of the screenbased upon assessment of the status of sets of calendar events inrelation to compliance criteria of the treatment regimen.

FIGS. 9g and 9h provides features related to user input and tracking ofsymptoms at baseline (e.g., obtained during onboarding) and then atlater times in the therapy, respectively. The symptoms are scoredqualitatively using symptom assessment criteria as “normal”, “moderate”or “high” which are defined for ranges of symptom scores.

FIG. 9i provides features that provide tracking progress feedback to auser.

FIG. 9j provides features of providing positive feedback and goalannouncements as part of coaching provided during the therapy interval.A treatment goal may be set as default or may be derived during theonboarding process 100 or afterwards in step 142. Providing encouragingnotifications as part of coaching can help motivate users as the therapyprogresses.

FIG. 9k provides features of informing users about advancing to a newstage of the treatment regimen such as from induction to maintenance.

Anatomical Data and Device Mapping.

In embodiments, training operations of step 104 or coaching operationsof step 140 are used with anatomical images. For example, in step 104the coaching module 50 h provides user instruction on how to positionthe device correctly for intended stimulation of an anatomical region asshown in FIG. 10b . An image may show or superimpose the devicecorrectly positioned and worn on a leg.

In embodiments the training 104 includes obtaining user input aboutanatomical data and stimulation related sensations. For example, usersare surveyed 142 to provide data related to device placement and theirassessment of stimulation and whether successful nerve recruitment hasoccurred. This includes being shown a display of a relevant body partsuch as a leg and foot in the case of SAFN stimulation, or arm or handin other application. The user can move a virtual image of the devicealong the image until it corresponds to the location that the user hasdecided to wear it or simply draw an “x” where the device is worn. Thetraining module 104 can provide feedback about if this is correct orincorrect. The user may also be surveyed about the location of skinstimulation or paresthesia. User friendliness and training outcome canbe improved by selecting or adjusting an anatomical image based uponuser demographics, gender, height, weight, body type, or othercharacteristics of a user that has been input by a user. If a userindicated they are a 65-year-old, black, female then an image of a legis selected from a library of leg images or line art representationsstored in the reference materials module 50 b. If the library containsimages for 3 age ranges, 2 genders, and 4 races (e.g., Black, White,Asian, Latino), then the image library of the module 50 b may comprise24 images.

Alternatively, during onboarding user surveying 108, the onboardingmodule 50 e can prompt a user to take a picture of their own leg withand without the wearable device attached. The EM module 46 can instructa user to operate a user device digital camera to obtain an image of thedevice being worn that is stored in the reference module 50 b. Atscheduled times during the treatment interval, as part of coaching 140,this image can be presented to a user by the App 21 prior to allowinguser to start the stimulation, to increase consistency of deviceplacement. Additionally, the system can survey a user to obtainadditional photographs of the device being worn according to a schedule.This may require that a photo be obtained at the start or end of everytreatment session. The image is stored in the user log. It can betransmitted with log information to remote computer 20 f and reviewed bya medical professional and to determine if device placement isconsistent and correct.

Virtual/Augmented Reality Mapping.

In embodiments, the digital ecosystem module 50 includes a virtualmodule 50 a that provides virtual reality (VR) or augmented reality (AR)functionality in combination with camera/video images recorded by auser's smartphone user device 20 a under control of the App 21. Forexample, the module 50 a software merges the image captured by thecamera/video with an image indicating where a user's saphenous nerve islikely to be (e.g., previously established through imaging data, orother mapping data that has occurred for the user, or based uponpopulation data), to provide for improved nerve targeting. Mapping datacan include locations where successful recruitment of the target nervepreviously occurred. For example, if a doctor performed assessment ofthe patient and placed the stimulation matrix 16 at a location, then theassociated VR image of that positioning is superimposed as a ghost imageupon the real time image recorded by the camera. The user can adjust theactual real life (RL) position of the device until it overlaps with thevirtual image. The use of VR helps confirm correct placement of thestimulation matrix when used independently at-home. The VR/RL comparisoncan be stored or transmitted to a computer 20 f at a remote location toallow remote guidance to the patient.

Feedback Using Sensed Data

In embodiments, the system includes a sensing module 44 configured torecord and process SNAP and/or EMG data. The sensed data signal may befiltered and provided to display or a speaker to allow a user to hear anevoked activity in contrast to background activity. The recorded signalmay be averaged over a selected period such as 30 seconds (e.g.,5-second segments with an average of 6 recordings) prior to beingpresented to the user. The sensed data can also be presented on a gridwhich shows a heat signature of the SNAP amplitude (or other measure ofevoked potential strength) as a function of where the stimulation signalcentroid was located on stimulation matrix.

In an embodiment, sensed data can be used to enable adjustment of astimulation signal that provides neuromodulation but is below sensationthreshold. This may be helpful if treatment is provided while thesubject is sleeping. In a method, the stimulation amplitude is increaseduntil the subject confirms sensory perception of recruitment. Theamplitude level is then decreased in steps (e.g., 5%) to determine ifthe stimulation is still sufficient to evoke a neural response.

In embodiments, sensed data may be used to assess or confirm nerverecruitment related to selection of amplitude, location of stimulation(i.e., field geometry), and selection of stimulation montage from a setof defined montages. This may occur in a closed loop manner thatautomatically adjusts stimulation parameters (amplitude, location) tomaintain a sensed response from the nerve that meets at least onedetection criterion.

When using SNAP recording and detection to confirm SAFN recruitment (forimplantable or wearable devices), at least one of a first pair ofelectrically conductive pads can be applied above the stimulation matrix(to record antidromic potentials) and a second pair can be placed below(to record orthodromic potentials), or both can be used. When recordingboth antidromic response and orthodromic responses as objectivemeasures, the two measurements can be compared, or combined, orindependently assessed to confirm recruitment. Confirmation of nerverecruitment can require at least one, or both, measures to be detected.Further, the relative delay (nerve conduction velocity) of the two typesof measured evoked responses can be compared as part of responseassessment.

When sensed data are used to confirm recruitment and set stimulationsettings, in either open-loop or closed-loop embodiments, then SaphLeveland SaphLocate features of the invention can be used to maintain“recruitment” of the target nerve. For example, the non-primary channelamplitude weightings can be set above zero and increased to achieve ormaintain successful recruitment of the target nerve. Sensed data mayalso be used by the system in closed loop systems that use control-lawsto maintain recruitment amplitude or latency measures within in aselected range.

Physician Locator/Connect.

In embodiments, triggers are defined in the system 10 a that prompt auser to connect with a physician for an in-person or virtual visit. Instep 126 the system can prompt a user to connect with a physician if theuser profile indicates the patient has may be inappropriate for thetherapy (e.g., suffers primarily stress incontinence rather than OAB).In embodiments, negative outcome treatment events as may be assessedwhen assessing treatment progress in step 144 serve as triggers thatcause the system 10 a to provide a defined contingent operation. Thesystem may transmit a flag value to a remote computer 20 f which is usedto modify a patient's record, and which can be scheduled for review by aqualified medical professional of a service provider. If merited thismay prompt the user to be contacted in a defined manner or may cause aremote telemedicine or in-person visit may be scheduled. Additionally,in embodiments, in step 144 the system may implement a physicianlocator/connect feature that includes any of the following operations.The locator/connect feature is implemented by the locator/connect module50 k to use the patient's location (assessed by address, zip code orother geolocating method) to provide the user with a list of nearby“EBT-Approved” urologists (or urology practices) that the user can thenselect. The list may also be based upon additional information storedby, or requested by, the system, such as the user's age andmedical/medication history. A patient can select the physician, may begiven the physician's contact information, be presented with the optionof being connected to the office to schedule an appointment, or canschedule an in-person or video consultation using the systems' softwareof the locator/connect module 50 k. Patients can be connected to aprofessional contingently based upon having a sufficient number ofremaining purchased “credit units”. Medical sessions can also occurusing texting or chat functionality or cellphone.

Upon acceptance of a user's request for medical consultation, as part ofstep 144 the locator/connect module can operate to request userpermission to send information to a doctor (i.e., a computer 20 c in thedoctor's office). In an embodiment, the user must actively providepermission for items to be sent to the doctor and provide a signature onthe touch sensitive screen of the user device 20 a which is presented bythe locator/connect module 50 k. The information may include: insuranceinformation, billing and address information, relevant medical history,and all information stored by the system 10 a on the neurostimulator 12,remote computer 20 f, or user device (e.g., user's smartphone 20 aoperating the App 21). The information can also include, for example,all information obtained during patient onboarding, user profileinformation, answers to survey items presented to the user, loginformation including history of stimulation including durations andparameter values, summary of compliance, notes from any priorconsultations with medical professionals (which is associated with auser's unique ID number and stored in the cloud), and other informationrelated to the user's medical history. When a consultation session isscheduled, this event is added to the calendar of the system's softwareor the calendar of the smart-device so that a reminder may be provided.

Negative treatment outcomes assessed during step 144 can also lead toadditional events 134 such as education with webinars on lifestylechanges or other medical treatment alternatives, and can lead to thesuggestion of incorporating alternative interventions (e.g., provisionof software-based therapy) that can be added to neurostimulation therapy(by a user or physician). If a user watches a video on implantedneurostimulators and wants to meat with a physician to discuss further,then the locator/connect module 50 k can restrict candidate physicianspresented to the user to those that are qualified or otherwise selectedto provide that therapy.

In an embodiment, if a physician or practice is selected by a useroperating the locator/connect module 50 k, then the user is providedwith the option of choosing involvement of the physician as part oftheir treatment plan and can opt to share summary or real-time data onan ongoing basis.

In embodiments, the digital ecosystem provided by module 50, includesfunctionality for a physician locator including module 50 k, which maybe triggered by events such as: if a positive response is obtained instep 108 during onboarding to a survey item or set of items designed toidentify conditions requiring medical assessment in step 126; as part ofstep 126 due to a user's medical history or medication information; ifduring treatment a user's therapy goal is determined to fail in step 144then the user is prompted with an option to be connected with a nearbyphysician/clinic; if a user requests an office visit through the App 21as part of step 146, for a reason known only to a user; If as part ofstep 148 which includes a scheduled remote review by a medicalprofessional of a user's data (e.g., as defined in the treatmentschedule or if this becomes remotely scheduled due to detection of amedical event such as a lack of treatment benefit); if it is prompted instep 148 due to a flag in the user profile due to an expiredprescription, or if a doctor has reviewed other information at a remotesite 20 c and determined a medical referral is warranted.

In embodiments, connection to a local physician in step 146 occursthrough a telemedicine application of the telemedicine module 50 d thatprovides software for videoconferencing with a doctor. This can allowfor requesting or scheduling an office or telemedicine appointment, theprovision of the medical office contact information, or the provision ofa remote meeting with a nurse practitioner who may in turn connect theuser with an appropriate local physician.

A local physician is identified as a physician located from a databaseof the system which will look up a local doctor using at least one ofthe following: the location of the user identified by GPS or zip code;insurance company information supplied by a user; information about auser's primary care provider or urologist which is stored in the system;or other method. Further, the method used and the doctor selected may beadjusted based upon what factor(s) prompted the user to connect with adoctor such as failing a therapy protocol, answers to a survey thatsuggested a constellation of symptoms which met criteria for a referralto a doctor for further evaluation (e.g., evidence of non-OABcomplications, medical conditions, or disorders potentially worthy ofassessment).

Contact Logs

In addition to the therapy program 130 updating the log information aspart of the startup/shutdown process 132, this can occur in step 150 inrelation to connecting with remote medical professionals in step 150. Inan embodiment, the system contains computer readable software code inthe user interface module 48 which manages telehealth operations of thetelemedicine module 50 d and operates the log module 50 m to create adata log of a user's remote telehealth history. The fields of a contactlog allow the tracking of time and content of any user messages whichthe user may send to a medical professional at a remote medical service.Additionally, the contact log managed by the log module 50 m stores datarelated to the user providing “event tagging” of potential relevantmedical events as part of step 150 which is invoked when a user entersinformation related to an event that they want stored or reviewed (e.g.,emergence of urinary retention). The log module 50 m can also log timeand content of questions submitted to a remote service (and answersreceived). These may include voice recordings or text messages which aretransmitted to a computer 20 f of a remote service for review orinformation stored locally on the system 10 a for later upload andreview.

Calendar Exports/Milestones Notifications

In embodiments, the digital ecosystem module 40 provided on a userdevice 20 a through an App 21 is designed to integrate with a smartphonecalendar program. Accordingly, scheduled therapy events defined in theRenew/maintain program can be presented on the calendar screen (see FIG.9f ) and can cause the App to provide the user with “push” or othernotifications under the Alerting module 50 j. However, the communicationmodule 45 can communicate export data from inside the App 21 as eventsor activities with defined reminders to a calendar specified by a user(e.g., exported into a user's Outlook or Google calendar using an “.ics”or “.vcs” file). Historical events and status (e.g. complete/incomplete)and scheduled future events are retained by the App 21 (with logs orother information stored on the device 12 and or remote computer 20 f)to form a complete record of events. This includes for example: whenstimulation sessions were scheduled and were skipped or occurred;“winning moments” such as when a patient achieved specific therapy goals(e.g., goals assessed over a selected period, “Zero leaks for the last 5days”, “Slept through the night for the previous 3 days”, or “Stimulatedevery day for 14 days, i.e. 100% compliance, etc.)

Similar to integrating log file information for the purposes of calendarexports, the coaching module 50 h can apply compliance criteria acrossthe integrated log file information that may be stored on theneurostimulator 12, user device 20 a, and/or remote computer 20 f. Forexample, if the user provides 1 or more stimulation sessions using theneurostimulator 12 without the user device 20 a then the compliancecriteria must be applied to the integrated log file after it hasimported usage data from the neurostimulator 12. In embodiments, this isdefined to occur at the start or end of a therapy session 132, orotherwise.

Implantable Device.

The invention may be realized using an implantable device rather than,or in addition to, a wearable neurostimulator. The implantable devicecan have a cylindrical shape like a BION or e-Coin shape or can usepaddle leads or other electrode form factors. Alternatively, the formfactor may be a slightly concave housing that corresponds to the notchthat runs alongside the tibia. It may have only 1 contact for providingstimulation (referenced to the housing) or may have a set of 2 or morecontacts, in which case, controls and methods for field steeringdisclosed for a wearable system are similarly used.

When stimulating the PTN, candidate stimulation locations can beconfirmed by visually or otherwise detected motor activity (e.g.,flexion of the first toe or fanning of all toes), such as changes in EMGor motor evoked potentials (MEPs). In contrast, candidate locations forSAFN stimulation can require the subject to confirm evoked sensationssuch as paresthesia or can be confirmed using SNAP detection. Fortreatment using the SAFN, a user's subjective assessment of implantationsites for one or more electrode contacts) may be hindered if performedafter providing local or general anesthesia (e.g., lidocaine orpropofol) due to interference with the patient's ability to confirmstimulation induced sensation. A two-stage implantation technique may berequired when using subjective assessment. Accordingly, in anembodiment, a first step includes assessing a candidate implantationlocation and/or a stimulation parameter by: a) transcutaneousstimulation corresponding to candidate implant points along the leg, orb) percutaneous stimulation at candidate locations (which may includedepth) such as provided by an insulated needle with a conductive tip (ortemporary subcutaneous lead). A device for cutaneous electrical nervestimulation and “nerve mapping” is the Stimuplex® Pen configured to workwith the HNS COMPACT Nerve Stimulator. This type of technology has beenshown to provide accurate assessment of nerve recruitment (e.g.,Bosenberg A T., et al, Paediatr Anaesth. 2002 June; 12(5):398-403).

Candidate locations can be assessed by subjective measures, nervemapping, or the combination using measures related to at least one of:minimum recruitment threshold; maximum comfort/tolerance threshold; painthreshold; a difference such as maximum difference between recruitmentand pain threshold; type, degree or region of induced paresthesia;presence/absence/level of co-activation of adjacent nerves or muscle,distance from a blood vessel, etc. Imaging data obtained using, forexample, ultrasound, X-Ray, or MRI can also be used to identifycandidate implant locations.

When the neurostimulator of the system 10 a is realized as animplantable device it may be programmed to transition from an inductionto maintenance schedule according to various rules such as: a)automatically after a predetermined interval calculated using aninternal counter or clock; b) if a user device 20 communicates anappropriate command either due to user selection or due to apredetermined interval lapsing as calculated by a counter or clock; orc) due to schedules, rules, and strategies described for the wearabledevice.

Treatment of Medical Disorders and Unwanted States.

In embodiments, system may be applied to treat, prevent, or improve manyunwanted conditions, symptoms, and disorders using stimulation of theSAFN or other nerve. These include for example, urinary or fecalincontinence, sexual dysfunction, chronic pelvic pain (CPP) syndromesuch as Orchialgia (persistent pain in the scrotum), ovarianpain/fibromyalgia, and interstitial cystitis (IC)/Painful BladderSyndrome (PBS). Treatment can also be related to vaginal dryness andpromotion of post-pregnancy, postpartum vaginal health. In addition toidiopathic OAB or underactive bladder disorders that may occur in theabsence of any underlying neurologic, metabolic, or other known causes,treatment may be provided to improve symptoms related to conditions thatmay mimic or evoke OAB symptoms, such as, urinary tract infection,benign prostatic hyperplasia (BPH), bladder cancer, bladder stones,bladder inflammation, or bladder outlet obstruction or due to proceduressuch as indwelling urinary catheter induced lower urinary tractinfections (LUTS), radiation induced changes of bladder or bowelactivity or sensitivity, post-prostatectomy OAB or other interventionsof the prostate. Certain medications may lead to OAB symptoms which maybe improved by neurostimulation, especially of the SAFN. Treatedconditions can also include non-obstructive urinary retention,genitourinary syndrome associated with menopause, enuresis, dysuria,erectile dysfunction, female sexual dysfunction and disorders. Furtherconditions may include constipation and irritable bowel syndrome (IBS &IBD) and related symptoms. Other peripheral nerves in the legs, arms,body, neck or head (e.g., cranial nerves) may also be suitable targetsfor treatment of these and other conditions and disorders. Inembodiments, the treatment system can be configured to provide bothstimulation and digital health support configured to treat disorderssuch as: Radiation induced: OA Bladder & Bowel; Nocturia; PostProstatectomy OAB.

The disclosed neurostimulation system may be used in treatment of pain(especially limb pain), reduced limb circulation, unwanted or hypo/hypermuscle activity (e.g., restless leg syndrome) and a host of medicaldisorders, via modulation of peripheral and/or central mechanisms. Thesystem operation is adjusted accordingly including, for example,treatment, coaching, user surveying, and symptom assessment and trackingof therapy progress.

Not to be limited by theory, although the basis and mechanisms ofacupuncture are not very well understood, candidate stimulation sitesmay be selected based upon locations used in acupuncture orelectroacupuncture, and then adjacent nerves can be assessed usingvarious stimulation parameters and treatment schedules to determine ifbenefit of nerve stimulation can be obtained. Stimulation sites andparameters can also be derived using data from animal models.

In embodiments, the wearable neurostimulation system is used to treatpain such as by blocking, masking, or competing with pain signals fromthe leg or foot. In an embodiment, the stimulation treatment is used totreat edema, either as an adjunct to providing stimulation for OAB, oras a separate treatment.

Decreasing Risk for Skin Events, Pressure Ulcers, and Injuries (PU/PI)

In embodiments, the wrap secures the stimulation matrix against a user'sskin with a low pressure that is sufficient to prevent it from slippingdown the leg. This allows the wrap to use stimulation matrix pads withlittle or no stickiness or “tack”. Alternatively, the wrap is configuredto provide a range of pressure if a user secures it moderately ortightly. In embodiments, the device, stimulation matrix, wrap, or othercomponent of the system 10 a incorporates pressure management andcontrol into its design. For example, a user control enables the user toadjust a spring compression pressure, or tightness of the wrap, whichbiases one or more pads against a user.

Unlike percutaneous electrode treatments which use skin piercing needlestranscutaneous stimulation with pressure can avoid various complicationsand risks to the user including infection, pain, and the reliance onmedical professionals to accomplish treatment. While using pressure withone or more matrix pads may have advantages, it can increase risk ofskin problems especially in users with medical disorders or certain skincharacteristics. Electrical stimulation can produce skin events (e.g.,irritation) which are typically minor and disappear shortly afterstimulation, but it is important to identify skin events that maydevelop into adverse events (AEs) for the user. The NiNA system providesfeatures for managing pressure and decreasing risk of skin eventsemerging or progressing in severity.

The term “skin event” is an umbrella term that can refer to the terms“pressure injury (PI)”, “pressure ulcer (PU)”, Medical Device PressureInjuries (MDPIs) “suspected deep tissue injury” (sDTI), “skin tear”,etc. all of which indicate an injury or potential injury to a user'stissue. A sDTI is defined as a purple or maroon localized area ofdiscolored intact skin or blood-filled blister due to damage ofunderlying soft tissue from pressure and/or shear. NPIAP 2019 guidelinesand WOCN 2016 Guidelines for Prevention and Management of PressureInjuries are incorporated by reference herein, and features of theinvention have been designed to address and adhere to these guidelines.

The mechanisms of pressure injury and overview of these guidelinessupport that, in embodiments, a wearable nerve stimulation system canincorporate moderate pressure levels to its stimulators or sensors usingshort treatment intervals (e.g., a range of 15 to 30, 60 or 120 minutes)with low risk of causing MDPIs and without transgressing relevant careguidelines.

As shown in FIG. 8b , scheduled treatment events related to assessingrisk for AE's 154 such as skin events provide, and can be adjusted basedupon, skin risk 164 scores as derived in steps disclosed in FIG. 8c .For example, a risk score is created during onboarding 100 or due to auser providing input which indicates increased risk when surveyed instep 142. Skin risk can also be adjusted based upon user input to thesystem due to skin risk symptoms noticed by a user. Users can provideinformation about their symptoms such as by event tagging 150, using anevent tagging screen including buttons for logging adverse events suchas skin events. An event tagging screen may include options such asredness, irritation, pain, discoloration, post-stimulation skinsensitivity or dryness, open sore, infection, blister, etc. In step 152,event risk operations can include invoking the steps of FIG. 8c . Forexample, user survey data can increase a skin risk score 174 if usershave indicated that they have increase risks such as more delicate skin,have medical history or conditions that increase risk of skin events.

In embodiments, during onboarding or afterwards, users are surveyedabout skin risk 120 the presence of conditions that produce greatersusceptibility for skin bruising, injury, irritation, tearing, or ulcer.Users are surveyed specifically about their arm, leg or other areaswhere stimulation will be provided with respect to presence or severityof any the following: Eczema; above average propensity for skinirritation or skin dryness; skin sensitivity; easily bruised; diabetes;lack of sensation; neuropathy; spider veins; varicose veins; skinallergies; sensitivity to hydrogel; or other condition that can increaserisk of skin injury or discomfort. If the user indicates any sensitivityor presence of these conditions during onboarding or at any point duringtherapy, the system can contingently implement operations that allow thecondition to be avoided, or surveyed about and tracked. The operationsmay include shortening a daily 30-minute stimulation treatment sessioninto two 15-minute sessions to provide a break for the skin of the user.The operations may include prompting a user with a treatment reminderwhich also includes a message to alternate the side of the body used toprovide treatment stimulation on sequential treatments. The operationsmay include fixed or adaptive algorithms that are configured todetermine occurrence or persistence thresholds for adverse events whichtrigger contingent operations. For example, an operation can be definedin response to a user indicating the emergence of bruising under thestimulation matrix in which a user is prompted to notify caregivers andhealth care professionals, or such notification is automaticallytriggered for a third party as defined during setup or by userpermission parameters.

Pressure Adjustment.

Too much or little pressure may both present problems. System featuresenable users to adjust the wrap compression level appropriately. Toomuch pressure will increase risk of skin events. When the wrap is madeof an elastic material, the material may be selected to provide aselected range of compression. As part of step 178, to further adjustpressure a user may be instructed to pull the one arm of the wrapthrough a buckle on the other arm of the wrap until the wrap is the samecircumference as their leg, and then to continue to pull until aselected number of markings provided visually on the wrap pass throughthe buckle. This will produce a corresponding pressure between thestimulation matrix and a user's skin based upon the wrap elasticity. Asa result, a desired pressure in an expected range is applied to thematrix (e.g., a range of 0.5 to 1.5 PSI).

Additionally, the wrap may incorporate buckles with incremental grooves(similar to buckles used on ski boots). After the wrap is secured to auser's leg, the user fastens the buckle using a first, second, or third,groove each of which are associated with a prespecified amount ofpressure. Additionally, finer adjustments to pressure can be obtainedusing screws that can be manipulated (wound) to constrict a bandrealized within or upon the surface of the wrap to decrease thecircumference of the wrap. In embodiments, the band may be configuredwith a manual air pump. In that embodiment, the user squeezes a balloonsimilar to what occurs when blood pressure it taken using an arm band.Similarly, a meter is incorporated into this solution which allows auser to measure the pressure applied to the band. The wrap may also beconfigured with adjustable tension controls such as a ratchet strap orelastic belts with buckle holes. The matrix may be provided with springswhich reside between the device 10 and one or more pads of the matrix16.

User Input, Sensed Data, and Assessment.

A PU/I or potential PU/I may be preceded by tissue that is painful,firm, mushy, boggy, warmer or cooler as compared to adjacent tissue. Asshown in FIG. 8c , in step 170 users are educated about these skin eventcharacteristics and in step 172 users are surveyed about PU/I presenceor severity.

User data obtained during the skin risk assessment 120 of onboarding 100or during therapy during step 142 can be used to adjust risk scores 122.Users can be asked about risk factors including, for example, diabetesmellitus, peripheral vascular disease, cerebrovascular disease, sepsis,and hypotension (low blood pressure can decrease capillary pressure), orthese risk factors can be entered into the system during onboarding byhaving the system communicate with an EMR system that is associated withthe patient. Conditions such as diabetes are relevant to risk of PU/Isince this may decrease a user's ability to feel pain related topressure or pressure injury and who may be slower to provide appropriateintervention.

Data obtained during the onboarding process may cause contingentadjustment 126 of a schedule of system prompts for the user to monitortheir skin for potential problems. The system may also set the state ofa status flag to “true” for a variable of “at increased risk for skinproblem” or otherwise increase a risk score 122. The system may alsoadjust characteristics of the treatment such as setting limit for theminimum interval between, frequency, or length of a stimulation session.If the flag status is set to true then several actions may occurcontingently 126 such as a) causing a visual signal such as a red LED ortext message to be displayed at the start of each stimulation treatmentto indicate to user or caretaker that the patient is at an increasedrisk for skin events, b) reminder are provided to decrease risk such asto alternate legs on sequential days or weeks, or to avoid a leg with asore or, c) the patient can be reminded to apply antibiotic ormoisturizing cream after providing stimulation.

Risk scores may also be increased due to surveying 120 that incorporatesusing survey items from the Norton Scale and Braden Scale (incorporatedby reference herein) which are commonly used prediction tools, or surveyitems based upon those scales. For example, a Norton score of 16 orless, or Braden Scale score of 18 or less, indicates increased risk forPU development and may increase a skin risk score 122 of a user. Use ofa validated scale for PU/I risk, or a modification of these scales, isused to adjust the risk score 122 in users at higher risk due theiranswer to 1 or more survey items.

Additionally, in step 120 users can be surveyed with items relevant totheir risks for injury related to pressure, friction or shear. Users canalso be surveyed about sensory perception, moisture, activity levels,mobility, nutrition, physical condition, mental state, activity, andmobility. Users can also be surveyed about characteristics such aspresence of dry skin, sensitivity, irritation, and skin conditions(e.g., cracks, scarring). A more frequent schedule of skin riskassessment or education may be scheduled if a user or caregiver notesany reason for increased risk (e.g., noting redness after stimulation,skin dryness, sores, or cracking at stimulation site) as part of eventtagging 150.

Adjusting Risk Scores and Contingent Intervention and ProtocolAdjustments.

If a user inputs information into the system that indicates increasedrisk then the system may adjust a skin risk score and operate tocontingently provide operations that decrease risk of injury, or whichcan decrease the severity of injury, or which aid in injury recovery.Risk scores can be quantitative and qualitative and can be stored in alook-up table that is operated upon by rules defined in the treatmentalgorithm. In addition to using skin risk data to adjust an overall skinrisk score, contingent operations carried out in steps 126 and 176 canbe defined according to values that are set for particular items. Forexample, if a “dry skin” variable is set to true then a user can bereminded to apply moisturizing cream after treatment, while this wouldnot occur if the “diabetes” variable is set to true.

If a user's score for a PU/I scale exceeds a selected threshold, then acontingent operation occurs such as: the patient is alerted to theincreased risk, or interventions or protocol adjustments contingentlyoccur.

While skin events can develop immediately, these can also develop within2 to 6 hours after insult. Accordingly, the system 10 a can beconfigured to query a user in step 172 about a potential skin eventbefore or after a stimulation session or this can be scheduled to occurseveral hours or days after the session has ended since users can appearto be free from the signs immediately after an insult. The NiNA systemprovides features that are appropriate to a user's risk level such asincrease instructions and reminders related to pressure injuryprevention when subjects are more at risk.

Pressure Mechanisms/Advantages

Use of pressure may decrease risk of skin-related discomfort andstimulation side effects since it can: a) decrease the stimulation levelneeded to recruit the nerve; b) decrease the spread of energy on theskin surface rather than through the skin, c) decrease impedance similarto that achieved by abrading the skin, and d) decrease the way thestimulation is perceived (e.g. by adding competing sensory information).Empirical measurements have shown that pressure can decrease impedanceby as much as 80% using a force of 2N to 4N. Without being limited totheory, applying pressure to cause the stimulator pad to push awaytissue and fluid may improve nerve recruitment due to a) a decreased thedistance between the target and the stimulation signal source, and b)changing the shape of the stimulation signal field between the two ormore stimulation pads of a stimulation circuit (e.g., decreased tissuevolume between two pads can increase the signal density). Decreasingpad-to-target distance (displacing the stimulator closer to the targetnerve) and the tissue volume between stimulation pads may decrease thesignal amplitude required to reach nerve recruitment threshold anddecrease unwanted co-activation of adjacent non-target tissue. Forexample, for a user with low skin event risk 176 if during onboardingupon being surveyed 108 paresthesia is not reported, then a user may beinstructed to increase pressure level of a stimulator, the matrix, orthe wrap.

If a user's risk score for skin events is below a selected level thesystem can operate to provide selected features and operations 176 thatincorporate the use of pressure during treatment 178. Biasing thelocation of an electroconductive pad deeper into the skin can improveboth nerve recruitment and sensing of evoked physiological activity. Aswell as decreasing distance between the stimulator and the target,pressure may also serve to decrease impedance which facilitatesstimulation and sensing of evoked nerve activity. For example, for auser with low skin event risk 176 when stimulating the posterior tibialnerve, use of pressure 178 can include two opposingly arrangedstimulators that press medially and laterally into the skin on theposterior side of the leg to improve nerve recruitment.

Pressure may be used to alter the sensory experience related tostimulation by increasing sensation of paresthesia or decreasing theamount of perceived pain or discomfort associated with a particularstimulation intensity. Not to be limited by theory, one mechanism forthis is activation of the nerves that sense pressure in the skin mayproduce signals that interfere with signals produced by nerves thatsense and transmit information experienced as pain.

Pressure can assist when treating patients with having excess tissuebetween the conductive pads and the target tissue. For example, use ofpressure may be adopted if during onboarding, upon being surveyed 108,for users who indicate characteristics that may suggest hurdles fornerve recruitment (e.g., overweight, an elevated BMI, believe they have“thick” skin, or those reporting edema) and who may have trouble withsuccessful stimulation of the anatomical target. Alternatively,adjustment of pressure can occur if during training 104 users are notable to recruit the nerve (e.g., due to anatomical differences in thelocation of a target nerve which hinders successful nerve recruitment orother factor).

Applying pressure to a stimulator or otherwise causing displacement of astimulator/sensor towards an anatomical target can enable or improvetherapy. Further, providing for features that deform skin 178 usingpressure, suction, or tension (e.g., pulling skin outward) to enablestimulators to improve the location for targeting a nerve, can allowgreater charge to be directed towards a target and provide advantages.For example, the device or matrix may be designed to pull, or otherwisedeform a body region to change its shape or to decrease the distancebetween a stimulator and a target nerve (e.g., compressing tissuesurrounding the posterior tibial nerve from the opposing lateral andmedial aspects will decrease the distance between the skin and targetnerve).

In embodiments, one or more of the stimulation pads 16 can have a raisedsurface that is configured to press into the patient's skin and to biasthe stimulator towards the target tissue. For example, at least onestimulation pad surface of the stimulation matrix pads can be formedwith a raised/offset surface such as a convex surface. Alternatively,the stimulation pad surface may be formed with one or more “dome-like”bumps that serve to direct the source of energy slightly deeper towardsthe target nerve and decreases the stimulator-to-target distance andamount of intervening tissue. The shape of the bump should be formed tobe smooth and shallow enough (e.g., less than 0.10 or 0.25 of an inch)that it does not cause too much pressure or sheer on a user's skin. Inan embodiment, the stimulation matrix is configured with one or morestimulation pads with deformations in their surface that enable aportion of the pad to protrude into, or otherwise deform, the patient'sskin.

In embodiments, as shown in FIG. 12, the stimulation pad 14 has aprojecting flat-rimmed flange 204 similar in shape to an axle hat nut orpush nut. The flange 204 includes an annular wall 200 extending from aconductive support ring 206 which is adhered to the stimulation pad 14.The flange 204 extends from a plane of the push nut or support ring 206to a an upper or top surface 202 of the flange 204. For example,electrode surfaces contain shapes formed like Hillman or Everbilt axlenuts, such as the % inch circular push nut having a diameter of about0.5 inches, a flange diameter of 0.2 inches, an annular wall of 0.2inches connecting the two at 90-degree angle and terminating with arounded top 202 that is pressed into the user's skin by the tension ofthe wrap. Alternatively, it may have a diameter of between 0.4 and 0.7inches, and a flange diameter of between 0.1 and 0.3 inches, and anannual wall of between 60 and 90 degrees with a height of betweenapproximately 0.1 and 0.3 inches. Using this “cap” design and electrodegel the inventors pilot work found perceived paresthesia was stronger,occurred at lower amplitudes of stimulation, and was more easilyobtained.

It has been found by the Inventors that applying a pressure of about1.65 lb. (0.75 kg) with a circular stimulation pad of 1.25 inches, toyield a force of 1.34 PSI can improve nerve recruitment: the test wasdone with circular electrode pad of 1.25 diameter, and PSI is calculatedby dividing 1.65 by (Pi*(1.25/2){circumflex over ( )}2). In embodiments,between 1 and 2 PSI is applied to each of one or more of the stimulationpads either by default or by user selection. The application of pressureis used to improve at least one of: a) the probability of nerverecruitment, b) the level of nerve modulation, c) the selectiveactivation of the target in the absence of co-activation of adjacentnon-target tissue d) the perception of the stimulation on the skin ofthe user and e) the amplitude of the stimulation signal associated withthe pain threshold.

Pressure can also be used to decrease the amplitude of the stimulationfield necessary to recruit the nerve (e.g., by decreasing stimulator totarget distance), and to increase the sensation of, or area of,paresthesia associated with recruitment of the nerve (e.g., by inducingpressure signals in the nerves that can affect sensory gating or whichcan cause lateral inhibition). In embodiments, from about or 0.4 to 0.6,or 0.6 to 0.8, or 0.8 to 1 pound of compression is applied to at leastone stimulation pad 16 or across all pads of a matrix. In embodiments,the components of the system 10 are designed to enable a user to providean adjustable amount of pressure within a range of about 0.5 to 3.5 PSI,and more preferably, between ^(˜)1.0 to 2.0 PSI (120 mmHg).

Pressure ulcers can develop when persistent pressure obstructs healthycapillary flow, leading to tissue damage and necrosis. Healthy capillarypressure generally ranges from 20 to 40 mm Hg (0.77 PSI), with 32 mm Hgconsidered the average. When pressure is above this range it can impedeblood flow to tissue. Illness severity and comorbidities can reducepressure required to obstruct capillary blood flow. Accordingly,pressure can be set in relation to a user's blood characteristics.

Managing Pressure and Skin Event Risk

In embodiments, the system incorporates features into the physicaldesign of the device, into the parameters of the treatment protocol, andinto the digital ecosystem that mitigate risk of PU/I, promotetreatment, and provide supplemental care to align with relevantguidelines. Good skin health can be promoted by default features or thatmay be adjusted according to one or more risk scores, or changes inrisks scores, or users preferences 176 associated with the emergence ofa skin event For example, the system lowers risk of injury throughfeatures related to:

a) Behavioral modification such as can occur in step 182 promotes userbehaviors that decrease risk of injury. For example, patients orcaregivers are instructed or prompted to alternate leg or arm used forstimulation to avoid repeatedly using the same treatment site. If a skinevent has been detected then the system can prompt a user to use analternate treatment location until recovery. If a user has indicated dryskin the system can prompt the user to apply moisturizer at thecompletion of the therapy session. The user or caregivers can also besurveyed about soreness or other skin/muscle discomfort as a scheduledevent or due to a decrease in usage so that they visually evaluate thetreatment area. If opted by a user, the system can include remindersabout applying ointments to skin after therapy.b) Education such as can occur in step 186 provides information andeducation to users about skin events (e.g., provide educational notesthat explain physical characteristics to notice such as redness thatpersists after therapy ends). Education can also instruct on how tocheck for signs of PU/Is.c) Education such as operating the ecosystem to educate patients andcaregivers about strategies to prevent PU/I's and tears, to promote PU/Ihealing. Education can also include providing information on nutrition,vitamins, supplements, and topical ointments that can assist withprevention and healing of PU/I's. Topics can include medical optionssuch as the use of cytokine growth factors (e.g., recombinantplatelet-derived growth factor BB), fibroblast growth factors, and skinequivalents. As well as material from relevant society guidelines. Theeducation material can include information on topical medicationointments that can be provided after stimulation.d) Education such as instruction for users and caregivers on how toadhere to national society guidelines through use of videos orinformational “snacks” which are provided using visual or auditorymessages and which may occur during therapy on the screen of a userdevice (e.g., bottom of FIG. 9d ). Information “snacks” are provided ona user device display, as text messages or push notifications on a userdevice, or by sending e-mails from a remote server 20 f.e) Education such as promoting education on correct application, use,and removal of the stimulation matrix to reduce unnecessary shear andpressure forces on the tissue. Correctly securing the wrap to the legwill decrease these risks. Using more than one size of wrap andstimulation matrix which is selected to be appropriate for user's legsize can decrease risks of uneven pressure or incorrect fit.f) Treatment protocol design such as can occur in step 180 having astimulation treatment program with characteristics appropriate for auser's skin risk. For example, providing an alert to pause stimulationtreatment and release the matrix pads from a source of pressure for aninterval (e.g., 1-5 minutes) before continuing to provide therapy. Thiscan also be realized by providing written instructions or automaticreminders to cause intermittent pausing of stimulation and pressurerelief. The device can be removed, or pressure can be relieved, atapproximately 5-, 10-, 15-, 20-, or 30-minute intervals instead ofproviding 30-60 minutes of stimulation continuously. Pressure reliefallows the microvasculature to recover and perfusion of the stimulationsite. Clinical guidelines vary but recommend pressure relief for atleast 15 to 60 seconds at intervals of every 15 to 60 minutes.Accordingly, to decrease MDPRI risk a user can treat for an interval(e.g., 15 minutes), then treatment is halted and pressure is relieved:NiNA will prompt the user to pause and release the wrap tension for 1minute before providing further stimulation.g) Treatment protocol design such as adjusting the treatment regimen sothat stimulation therapy occurs less often if skin events emerge orpersist to allow sufficient recovery time. Since PU/Is may not to healin a timely manner due to ongoing pressure by devices that are wornchronically or for extended periods. Although the device is only wornfor 30-60 minutes and used daily during induction, a less frequentschedule may be helpful.h) Nutrition such as realized in step 188 with users being reminded thatproper nutrition is important (e.g., reminded to consume a minimumamount of daily protein and vitamin) since nutrition is associated withwound prevention and healing.i) Nutrition and dietary support such as nutritional education, prompts,which are provided (and supplements shipped) that decrease risks posedby impaired neutrophil function, overproduction of reactive oxygenspecies, free fatty acids and inflammatory responses. Thesepathophysiologic changes contribute to direct cellular damage, vascularand immune dysfunction.j) Personalized Pressure adjustment such as realized in step 178decreasing pressure for patients who are more at risk using calibratedsprings or manual/electric pumps to supply a selected ranges of pressureto the wrap. In an embodiment, the wrap is configured with settings ormarking that allow the user to set the amount of pressure (e.g., pullingthe wrap until a particular marking matches up with a different markingto provide a calibrated amount of tension). Further, wraps can bemanufactured to provide high, medium, and low amounts of pressure. Forexample, adjusting elasticity/stretch characteristics or incorporatingadjustable buckles, and other means for adjusting the strength ofsecuring.k) Personalized Pressure adjustment. Additionally, pressure can bemodulated to be dynamically adjusted above and below a patient's bloodpressure measurement which can be assessed by the system prior totherapy, or a blood pressure level that is estimated, or according toother risks or attributes of a user such as age, or data/measurementswhich can be made using sensors of the system or by independent testingwhich is related to SpO2 (Blood Oxygen Saturation level), pulse ratemeasurement, blood perfusion index and combination metrics whichinclude, for example, both pulse and perfusion. Measures can includePlethysmograph and Perfusion Index Hydration, bioimpedance, averageheart rate, and metabolism.An individual's risk can be assessed as part of a “baseline assessment”provided by a doctor. The baseline assessment can also include makingpatient anatomy measurements (leg circumference; body mass index;severity or type of edema; presence of injury or vascular condition;varicose veins) and providing system components (wrap characteristicssuch as size, elasticity, or pressure; stimulation matrix size; padstiffness or design including components that press into the user'sskin) that are appropriate for the patient.l) Bioimpedance assessment such as can occur in step 190, and includesassessing bioimpedance which may be used to provide body compositionanalysis that decomposes a user's body into four components or measuresassociated with, for example, fat, muscle mass, minerals, and bodywater. A suggested pressure setting, range of pressure, and stimulationprotocols used during treatment can be adjusted based, in part, upon oneor more of these measurements. Various sensors and stimulators (e.g.,vibration, temperature, moisture, and ultrasound transducers andtransceivers) may be incorporated into the stimulation matrix, thestrap, or other system component.m) Monitoring and Management such as can occur in step 182 includingprompting and obtaining confirmation that a user periodically checks andprovides input to the system which confirms the user has checked forpotential injury. If the patient reports any discoloration, changing insensitivity, or presence of pain then the patient can be referred to amedical doctor, a remote session is initiated, or the system prompts theuser to use the other leg.n) Monitoring and Management such as configuring the software to reminda user to check for sore, redness periodically before the system isworn, or on a future date since PU/I's can develop hours, days or weeksafter insult.o) Monitoring and Management such as adjusting the treatment program tosurvey more frequently or asking a user if the system can monitor moreclosely when a patient has more comorbidities or is in worse health(physical or mental). If the user allows this, then the user can then beprovided with more frequent surveying or remote telemedicine supportwhich includes visual observation of the treatment site by a medicalprofessional.p) Skin health tracking such as may occur in step 192 and includeinstructing a patient to take photographs that are logged and which canbe sent for review to ensure absence of injury. In an embodiment, thesystem uses video or camera-based software to collect, assess, store,and submit image data of a user's leg using image logging. The dataallows a user, professional, or custom software to monitor skin healthstatus at the stimulation sites and enable real-time monitoring andearly detection of changes to deter progression of new injuries. Theimage data may be assessed via remote monitoring of image data thatoccurs periodically, upon user request, or as prompted by software thatevaluates image data. In an embodiment, the user can take a picturewhich is stored by the device 20 a and/or transmitted to a remotecomputer 20 f for visual review by a medical professional. The imagedata can include log data that enables comparison of current image datato prior image data, such as to images obtained 1, 2, 4, and 7 daysprior. Software of the system can guide a user so that images areobtained with methodology for restricting the distance, angle, andlighting of images within acceptable ranges to augment consistency. Thesystem can include an accessory that positions a user smartphone device20 a in the same position relative to a limb during image acquisition(e.g., a physical frame that is placed against the leg).

In an embodiment, surveying 142 is configured to obtain and manage aphotographic log of the log module 50 m to identify and track apotential device-related skin problem. For example, surveying 142includes periodically prompting a user to take a photograph of a bodypart where stimulation is provided (e.g., once a week). The image can beanalyzed by software of the App 21 designed to identify, measure, ortrack physical characteristics of bruises, irritation, or pressuresores. The surveying 142 module can be configured to adjust the scheduleof photographic log entries, or questions about skin problems, basedupon a user indicating skin risk as part of step 120 or based upon auser indicating skin risk as part of being surveyed 142 at scheduledtimes.

In embodiments, the Adverse Event (AE) module 50 n may prompt a user atthe end of every treatment session or periodically about whether theymay have experienced any stimulation related problem. If a user answerindicates a potential problem then the user is surveyed further such asbeing provided with a picklist including, for example pain, sensitivity,redness, soreness, dryness, tear, bruising etc. If a user indicates abruise or redness has appeared then this “risk event” can cause the AEmodule 50 n to adjust the a parameter value of the coaching model inorder to cause it to prompt a user to take a picture of the body partevery day until the event is no longer indicated by the user as present.The tracking provided by the AE module 50 n allows a user, or medicalprofessional to track a risk event over time. By taking a picture of abruise over multiple days the progression of the risk event can becompared to see if it is worsening, stable, or improving. If the statusof a candidate risk event (e.g., a minor skin sore) worsens then theuser can be referred for a medical review which may occur as an officevisit or by telemedicine video call through a telemedicine module 50 dof the digital ecosystem.

The photographic log activity can be adjusted by the log module 50 maccording to user survey data obtained during onboarding when a userfirst uses the system 10 a. For example, a user can be asked aboutcharacteristics related to increased risk for skin tears or if theybruise easily, are diabetic, and/or have various dispositions such aslow blood that can lead to an increased risk of adverse skin events suchas pressure ulcers. Low blood pressure (e.g., low diastolic or systolicblood pressure such as diastolic <49 mm Hg) may decrease the pressure ofmicrocirculation near and under the stimulation pads due to pressureapplied during treatment, and increase risk for bruising or pressureulcers with repeated use of a wearable stimulator.

q) Signaling such as may occur in step 194 when used in a careenvironment like an assisted living facility, conditions which areassociated with increased risk can be flagged by a caregiver, or nurse.For example, impaired sensory perception due to a medical disorder suchas neuropathy, an impaired ability for the patient to communicatediscomfort, for example, language barriers, cognitive impairment, orother condition. This flag may cause a visual indicator of increasedrisk for PU/I to appear on a nursing station, on a user device 20 a, orelsewhere so that appropriate care is provided to a patient. Thismonitoring can be extended to risk of skin tear and selection ofelectrode pads with less tack.r) Signaling such as providing signaling for at-risk patients isaccomplished, for example, using a red LED on the device, an alert onthe user device, or notification presented to care providers by theecosystem software which may communicate with devices of people orhealth systems which are providing care. The signaling may notifycaregiver staff that certain care is important such as alternating legs,checking for bruising or skin problems, providing pressure relief breaksduring treatment, or providing post-treatment care such as leg messageor heat/cold therapy.s) Adjustment of device components, such as may occur in step 178 if thepatient profile is adjusted so that they are shipped proper systemcomponents such as stimulation matrix replacements devoid of features toincrease pressure or use of conduction surface with a protuberant edge;or a wrap model is selected that supplies less pressure; or a lowerpressure setting is used in adjustable pressure accessories that isprovided with the system. A stimulation matrix or band that applies lesspressure can be selected according to a user's skin risk.t) Provision of adjunct therapies such as may occur in step 184 and asdisclosed below. Providing adjunctive therapy, before, during, or afterstimulation may deter PU/I risk.

Adjunctive Therapy to Decrease Risk of, or Treat, MDPIs.

Adjunctive therapies can promote PU/I prevention and treatment. Theappropriate adjunctive treatment may be related to PU/I characteristicssuch as stage, severity, size. In embodiments, adjunctive therapy mayinclude, for example, electrical, thermal, and negative-pressuretherapy. This can be prompted or provided by the system before, during,or after electrical stimulation to treat a disorder such as OAB.

a) Adjunctive electrical stimulation can deter or promote healing ofPU/Is such as stimulating using selected frequencies which have beenfound to promote healing. Adjunct electrical stimulation treatmentprotocols are provided to, for example, increase capillary density andperfusion, promote the response of fibroblast, neutrophil macrophagecollagen, and DNA synthesis, and, increase the number of receptor sitesfor specific growth factors. The stimulation pads used to provideadjunct electrical stimulation may be the same or different than thoseof the stimulation matrix which are used to provide treatment of adisorder (e.g., pelvic floor disorder). For example, in an embodimentpulse frequency is set to the 100 pulses/second range and the voltage isset (e.g., 50 to 150 volts) sufficient to deliver a current thatproduces a moderately strong but comfortable tingling sensation underthe pads or a just-visible muscle contraction. In embodiments, thepolarity of the electrodes placed on or straddling the PU/I can beadjusted depending on the wound's clinical needs. For example, topromote autolysis, the stimulation protocol may use positive polarity toattract negatively charged neutrophils and macrophages. Alternatively,to encourage granulation tissue development, the protocol may usenegative polarity to attract positively charged fibroblasts. Tostimulate wound resurfacing, positive polarity may be selected toattract negatively charged epidermal cells. The schedule of adjunctiveelectrical treatment can be 1-2 hours a day, 5 to 7 days a week, for along as needed.b) Heat therapy (normotherapy): heat is used to increase blood flow andpromote fibroblasts, increase metabolic demands of tissue to increasemicrocirculation, and modulate other factors associated with PU/Ihealing. The system includes an accessory for providing heat to skin.This may include thermal energy caused by sound, vibration,light/LED-induced heating of skin or fabrics or substances designed toretain or provide heat/cooling to skin. It is likely that modulation ofheat after the application of pressure/stimulation would be mostbeneficial.c) Microcirculation therapy: stimulation such as vibration, sonic, orultrasonic energy is provided to increase microcirculation. Treatmentmay include short (e.g., 10-sec) bursts of vibration at a selectedfrequency (e.g., 20-50 Hz) and amplitude (e.g., 1-2 mm) followed by apause (e.g., 5 to 10 sec) to increase skin blood flow. In an embodiment,the wrap is provided with a vibration transducer and the control moduleis provided with stimulation protocols for adjunctive therapy, or thesystem includes an accessory device to provide the adjunctive therapy.d) Negative pressure wound therapy such as can be s provided by thesystem using an accessory with a pump to supply vacuum over an area of aPU/I.

Additional Health States and Measures.

When the system is used to provide treatment of a pelvic floor disorder,or other disorder, that requires ongoing repeated use of the device on adaily, weekly, or monthly basis, then, monitoring of changes in bloodflow in the limb versus baseline measurements can allow monitoring ofadditional health states and conditions of a user. In embodiments, thesystem can be used for adjunctive monitoring of vascular disease andneuropathy before, during, or after providing stimulation for thetreatment of overactive bladder. For example, the neurostimulatorsensing module 34 can adopted to monitor peripheral blood flow in thelimb using a sensor such as an integrated piezoelectric sensor arrayand/or ultrasound measurements.

In an embodiment, cardiovascular measures such as heart ratevariability, blood pressure, heart rate, and oxygen saturation may beincorporated to provide adjunct monitoring of health states andconditions that are different than the primary condition for whichstimulation treatment is being provided. Additionally, these measurescan be used to assess the user's response to stimulation treatment fordisorder such as a pelvic floor disorder.

Other measures may be obtained using a ring-like accessory into thesystem such as those obtained by the Oura ring (https://ouraring.com/),incorporated by reference herein, related to cardiovascular measures,heart rate variability, sleep quality and duration, etc.

In an embodiment, monitoring of an additional health state or conditionincludes peripheral neuropathy monitored, for example, by detectingchanges in nerve conduction velocities measured in response to astimulation signal and sensed by a system component.

All embodiments may deviate from that described and are not meant to belimiting of the spirit of the invention. Various modifications,adaptations, and alternative designs are of course possible consideringthe above teachings. Therefore, it should be understood that within thescope of the appended claims the invention may be practiced otherwisethan as specifically described herein. Various combinations orsub-combinations of the specific features and aspects of the embodimentsdisclosed above may be made and still fall within one or more of theinventions. Further, the disclosure herein of any feature, aspect,method, step, characteristic, quality, attribute, element, or the likein connection with an embodiment can be used in all other embodimentsset forth herein. Any prior art reference or article cited in thedisclosure is incorporated by reference herein for all purposes.

Features and aspects of the disclosed embodiments can be combined withor substituted for one another to form varying modes of the disclosedinventions. The scope of the present inventions herein disclosed shouldnot be limited by the disclosed embodiments described above. Moreover,while the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,that the invention is not to be limited to the forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.

Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by a user orthe software; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “placing the matrix” include “instructing on theplacement”. The ranges disclosed herein also encompass any and alloverlap, sub-ranges, and combinations thereof. Language such as “up to,”“at least,” “greater than,” “less than,” “between,” and the likeincludes the number recited. All titles and section headings are forreadability purposes and are not intended to limit the invention in anymanner.

In embodiments, not all of the steps of a method shown in the figuresmust occur, or occur in the same order as shown in the figure.Additionally, method steps shown in the figures can occur in isolationor be combined with methods shown in other steps.

What is claimed is:
 1. A transcutaneous stimulation system comprising: astimulation module having an electrical stimulus generator fortransmitting electrical signals through a plurality of electricalgenerator channels; a control_module electrically coupled to saidelectrical stimulus generator for activating or deactivating each ofsaid electrical generator channels in accordance with a predeterminedstimulation protocol having a set of at least two stimulation montageswith a weighting value defined for each of a set of activated pads. astimulation matrix defining a plurality of pairs of electricalstimulation pads_which are adapted to be positioned in a fixed andpredefined arrangement on a user's skin, each of said pairs ofelectrical stimulation pads having a cathodic pad and an anodic padelectrically coupled to a respective cathodic and anodic electricalgenerator channel, each of said electrical stimulation pads being in (1)an active state when a respective electrical generator channel isactivated, and (2) an inactive state when a respective electricalgenerator channel is deactivated; a first stimulation montage definedfor the pads of the stimulation matrix where each of said electricalstimulation pads is in said active state or said inactive state. atleast a second stimulation montage defined for the pads of thestimulation matrix where at least one of said electrical stimulationpads is in an inactive state when said at least one stimulation pad isin said active state in said first stimulation montage; and, a userinterface device for permitting user input that is used to causetransitioning said stimulation matrix from said first stimulationmontage to said at least second stimulation montage.
 2. Thetranscutaneous stimulation system as recited in claim 1 where saidplurality of electrical generator has at least four electrical generatorchannels.
 3. The transcutaneous stimulation system as recited in claim 1where said stimulation matrix has at least four electrical stimulationpads.
 4. The transcutaneous stimulation system as recited in claim 3where said electrical stimulation pads of said stimulation matrix aredisplaced each from the other in a predefined geometrical pattern
 5. Thetranscutaneous stimulation system as recited in claim 4 where saidgeometrical pattern of said electrical stimulation pads define atriangular envelope.
 6. The transcutaneous stimulation system as recitedin claim 1 including a stimulation protocol of said stimulation moduledefining a set of predefined stimulation montages for said stimulationmatrix where each of said predefined stimulation montages hasindividualized electrical stimulation pads with predetermined active orinactive states.
 7. The transcutaneous stimulation system as recited inclaim 1 including electrical generator settings of the first and secondstimulation montages being adjustable for enabling said transitioningbetween said first and said second stimulation montages to be performedthat meets a perceptual criteria.
 8. The transcutaneous stimulationsystem as recited in claim 7 wherein the perceptual criteria is designedso that the transitions between the at least first and second montage isdefined to be above the just noticeable difference found using a groupof users so that a user is more likely to notice the transitions.
 9. Thetranscutaneous stimulation system as recited in claim 7 wherein theperceptual criteria is designed so that the transitions between the atleast first and second montage is defined to enable the transitions tooccur without causing perceived jumps in intensity to be above a levelthat is determined to be distracting for a group of users so that a useris more likely to be capable of noticing changes in recruitment evokedparesthesia.
 10. The transcutaneous stimulation system as recited inclaim 1 wherein the weighting value defined for each channel is used toadjust at least one of: an amplitude of a stimulation signal provided byan electrical generator stimulation channel associated with a pad, andthe pulse width of stimulation pulses of a stimulation signal providedby an electrical generator stimulation channel associated with a pad.11. The system as recited in claim 1 wherein amplitudes of theelectrical generator signals set in the at least said second stimulationmatrix montage are set in relation to the (a) electrical signalamplitudes in the first stimulation montage, and, (b) the difference inthe number of stimulation pads in the active or inactive states.
 12. Thesystem as recited in claim 11 wherein said first stimulation montageincludes two active state stimulation pads and the second stimulationmontage includes four active state stimulation pads where the amplitudeof the electrical generator signal for at least a portion of thechannels of said second stimulation montage is greater than at least 50%of the amplitude in said first stimulation montage.
 13. The system asrecited in claim 11 wherein said first stimulation montage includes twoactive electrical active stimulation pads and said second stimulationmontage includes four active electrical active stimulation pads with theelectrical generator signal for at least a portion of the channelsof_the second stimulation montage being within the range of 60%-90% ofthe electrical generator signal of the first stimulation montage. 14.The system of claim 1 wherein said first stimulation montage has sixelectrical stimulation pads in said active states coupled respectivelyto said electrical generator channels with each of said electricalgenerator channels having a weighted amplitude signal in the range of70%-100% of a predefined electrical signal in five of said stimulationmontages for providing predetermined amounts of stimulation betweenopposingly positioned electrical stimulation pads.
 15. The system ofclaim 1 wherein the set of stimulation montages includes a selected setof montages that has previously been shown in a group of patients totypically enable perception of movement of an electrical field from oneside of said stimulation matrix to an opposing side of said stimulationmatrix in a transition between said first stimulation montage to said atleast said second stimulation montage when said stimulation montages aresequentially selected.
 16. The system of claim 1 wherein the set ofstimulation montages includes between 3 and 7 stimulation montages. 17.The system of claim 1 wherein the set of stimulation montages includes 5stimulation montages.
 18. The system of claim 1 wherein the set ofstimulation montages further includes an “all” montage in which theweights of all channels are approximately the same.
 19. The system ofclaim 1 wherein a stimulation matrix and montages are adapted to providestimulation of the saphenous nerve by providing targeted stimulation tothe medial region of a user's leg.
 20. The system of claim 1 wherein theset of stimulation montages includes a selected series of montages tocause a maximum of an electrical field strength to move from a first toa second side of the stimulation matrix as stimulation montages aresequentially selected.